SDRAN posts job applications for Regulatory positions for firms in the San Diego County area only.
We do not accept postings from recruiters. Postings will remain on the website for approximately 30 days.
To place a job posting, please send a brief description of the position (200 words or less) with contact information to
Greg Payne - SDRAN Communications & Membership at gpayne1@cox.net

Pharmaceutical Research & Development, LLC (Johnson & Johnson)

Manager Regulatory Affairs (7/18/08) Pharmaceutical Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager Regulatory Affairs, located in La Jolla, CA. The Early Development Global Regulatory Affairs Manager provides support for early development compounds in the assigned portfolio within the CNS/IM therapeutic areas for studies up to and including "Proof of Concept" studies. The position is responsible for assisting in global filings, preparation of responses to Health Authorities (HA), and for assembling IND, CTA and CTD dossier components as well as reviewing them critically. A minimum of a Bachelors degree in relevant life or health-related science is required. A minimum of 3 years related industry (pharmaceutical) experience in regulatory affairs is also required. Some of this experience should be with US IND filings (experience with CTAs in addition is also helpful). Previous experience with early development activities (e.g., nonclinical studies, pre-IND planning) for small molecules is preferred. Previous experience with electronic submissions is preferred. For a full job description please visit our website at www.careers.jnj.com noting requisition number 0807595 If you are interested in this position, please apply online at www.careers.jnj.com noting requisition number 0807595, and send a copy of your resume to mhannan3@corus.jnj.com

Covidien

Regulatory Affairs Specialist (7/18/08) Nellcor Puritan Bennett is now the Respiratory and Monitoring Solutions business unit of Covidien. Our systems are used to monitor, diagnose and treat respiratory disease and sleep disorders, and they provide life sustaining ventilation and oxygen support for patients. Job Title: Regulatory Affairs Specialist Ensures compliance to FDA and other applicable regulations. Prepares, analyzes, and submits dossiers to various governing agencies in supporting business growths. Supports applicable regulations including ISO, local, state, and/or federal requirements. Essential Duties & Responsibilities: •Monitor and provide management with impact of changes in the Regulatory environment. •Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. •Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators. •File annual notification, annual establishment, state, federal registrations, product changes of FDA, Health Canada, EU, notified bodies, and other regulatory agencies. Qualifications: 5-8 years of RA experience B.S. or B.A. degree required. Must have knowledge of U.S. and/or European/International regulations and standards Experience in preparing regulatory submissions Experience interacting with FDA and/or other regulatory agencies For further information regarding this and other Covidien opportunities go to www.covidien.com/careers. Apply to: Deborah.Cason@Covidien.com EEO/AA

Gen-Probe Inc.

Manager Clinical Operations (7/18/08) “The Power to Look Deeper” Gen-Probe is a global leader in research, development & manufacturing of nucleic acid diagnostics that offers exciting opportunities in the advancement of human healthcare. Recognized as one of San Diego’s leading biotech companies, we offer a state-of-the-art facility in a prime location with world-class benefits. We’re currently looking for team members who have “The Power to Look Deeper” in developing the best products, technologies and service. “The Power to Shape Your Future” Are you an experienced Manager of Clinical Operations looking to advance your career? Here at Gen-Probe we are working on developing diagnostics that can save lives through early detection of many current and future health threats. Would you like to contribute to this important work? If so, we want to hear from you! DESCRIPTION OF POSITION RESPONSIBILITIES: • Designs, leads and manages all phases (I-IV) of complex clinical trials. • Develops data model and data analysis plans. • Solicits & negotiates clinical study budgets & contract language. • Ensures study protocols, informed consent & other documents are complete & consistent with FDA regulations. • Presents and/or negotiate with FDA to gain approval. • Develops clinical study budget & manage expenses. • Ensures complete & accurate data collection, QC, & record keeping. • Prepares draft & final clinical reports. • Identify opportunities to develop scientific abstracts, presentations, & manuscripts for publication. • Represents the department as needed. • Oversees CRA’s, monitors, trial sites & trains project staff RELATED BUSINESS/TECHNICAL SKILLS, KNOWLEDGE, ABILITIES: • Advanced knowledge of clinical trial databases. • Working knowledge of statistics to apply and understand appropriate data analysis for clinical trials. • Excellent communication skills – experience presenting to diverse groups of all levels & interacting with members of senior management. EDUCATION AND EXPERIENCE REQUIREMENTS: • Typically requires a BS/BA degree and a minimum of 8-10 years related experience OR MS and 6 years OR PhD and 4 years. Gen-Probe offers a dynamic and innovative work environment along with excellent benefits that include 100% sponsored medical/dental/vision benefits, stock options (NASDAQ:GPRO), bonus potential, 401(k) w/company match, paid vacation/sick time /holidays, assistance with continuing education, on-site fitness center, and our own Waterfall Café. We invite you to view our Career Video! http://www.view-career-video.com/videos/genprobe/ Please apply online by visiting: http://www.gen-probe.jobs

Regulatory Affairs Specialist (7/18/08) “The Power to Look Deeper” Gen-Probe is a global leader in research, development & manufacturing of nucleic acid diagnostics that offers exciting opportunities in the advancement of human healthcare. Recognized as one of San Diego’s leading biotech companies, we offer a state-of-the-art facility in a prime location with world-class benefits. We’re currently looking for team members who have “The Power to Look Deeper” in developing the best products, technologies and service. “The Power to Shape Your Future” Are you an experienced Regulatory Affairs Specialist looking to advance your career in the biotech Industry? Here at Gen-Probe we are working on developing diagnostics that can save lives through early detection of many current and future health threats. Would you like to contribute to this important work? If so, we want to hear from you! DESCRIPTION OF POSITION RESPONSIBILITIES: • Prepare 510 K submissions. • Prepare hardcopy and electronic information packages for submission to regulatory agencies • Participate on product development core teams as regulatory representative • Create regulatory strategies for domestic and international markets • Monitor and receive deliverables for submissions • Write and/or edit submission documents using regulatory templates • Assemble paper and/or electronic copies for submission • Assess manufacturing process and labeling changes for regulatory reporting impact • Keep informed of new and revised regulations; disseminate information as directed by management • Interact with regulatory agencies • Prepare internal procedures for continuous process improvement RELATED BUSINESS/TECHNICAL SKILLS, KNOWLEDGE, ABILITIES: • Solid computer skills • Advanced written and oral communication • Experience and knowledge of IVD manufacturing EDUCATION AND EXPERIENCE REQUIREMENTS: • Typically requires a BS/BA degree or equivalent and a minimum of 2-5 years experience OR MS degree or equivalent and 1-3 years experience. Gen-Probe offers a dynamic and innovative work environment along with excellent benefits that include 100% sponsored medical/dental/vision benefits, stock options (NASDAQ:GPRO), bonus potential, 401(k) w/company match, paid vacation/sick time /holidays, assistance with continuing education, on-site fitness center, and our own Waterfall Café. We invite you to view our Career Video! http://www.view-career-video.com/videos/genprobe/ Please apply online by visiting: http://www.gen-probe.jobs

Clinical Scientist (5/30/08) “The Power to Look Deeper” Gen-Probe is a global leader in research, development & manufacturing of nucleic acid diagnostics that offers exciting opportunities in the advancement of human healthcare. Recognized as one of San Diego’s leading biotech companies, we offer a state-of-the-art facility in a prime location with world-class benefits. We’re currently looking for team members who have “The Power to Look Deeper” in developing the best products, technologies and service. “The Power to Shape Your Future” Are you an exceptional Clinical Scientist with at least 8 years of experience in IVD? If so, and if you have strong clinical data management experience, excellent communications skills with cross functional teams, strong clinical trial experience and possibly even experience in the area of oncology – We Want to Speak to You! DESCRIPTION OF POSITION RESPONSIBILITIES: • Designs, leads and manages the most complex clinical trials. • Develops data model and data analysis plans. • Solicits & negotiates clinical study budgets & contract language. • Ensures study protocols, informed consent & other documents are complete & consistent with FDA regulations. • Presents and/or negotiate with FDA to gain approval. • Develops clinical study budget & manage expenses. • Ensures complete & accurate data collection, QC, & record keeping. • Prepares draft & final clinical reports. • Identify opportunities to develop scientific abstracts, presentations, & manuscripts for publication. • Represents the department as needed. • Oversees & trains project staff. • Advanced knowledge of clinical trial databases. • Working knowledge of statistics to apply and understand appropriate data analysis for clinical trials. EDUCATION AND EXPERIENCE REQUIREMENTS: • Typically requires a BS/BA degree and a minimum of 8-10 years related experience or MS and 6 years or PhD and 4 years. Gen-Probe offers a dynamic and innovative work environment along with excellent benefits that include 100% sponsored medical/dental/vision benefits, stock options (NASDAQ:GPRO), bonus potential, 401(k) w/company match, paid vacation/sick time /holidays, assistance with continuing education, on-site fitness center, and our own Waterfall Café. We invite you to view our Career Video! http://www.view-career-video.com/videos/genprobe/ Please apply online by visiting: http://www.gen-probe.jobs

CP Kelco, JM Huber Company

Regulatory Affairs Assistant (temporary August 18-Dec 13) Full time (5/14/08) Regulatory Affairs Assistant (temporary August 18-Dec 13) Full time CP Kelco, JM Huber Company 2025 East Harbor Drive San Diego, CA 92113 Need full time person with some experience in regulatory compliance to provide temporary assistance. Good experience and developmental opportunity for someone with minimal Regulatory experience. RESPONSIBILITIES Provide support to the Regulatory Affairs (RA) department for the following at a minimum: Customer Requests (CR). Process CRs as received from RA Department Administrator. Process CRs directly with Standard Replies or research to provide correct RA information. RA Sr. RA Manager can provide guidance. Coordinate responsibilities with RA Department Administrator to finalize (route internally or direct reply to customer). Track and close requests, as necessary, in Lotus Notes database. RA Standard Replies. Update and post current RA standard replies to RA Sharepoint site. RA Sr. RA Manager can provide guidance. RA SharePoint site. Update as required under direction of Sr. RA Manager RAR (Regulatory Affairs Requests). Keep RAR Log up to date. Coordinate with RA Director and Sr. RA Manager for each project. Send RAR reports and close out RARs as directed. Distributor Extranet. Coordinate with QA and IT to continue the development of Distributor. RA Sr. RA Manager can provide guidance and has oversight of this project. Literature Search/Reports. Perform literature and regulation searches as directed by RA Director or Sr. RA manager in support of RA projects. Ability to read and interpret regulations and provide analysis/report to supervisor. Provide support for other RA projects as necessary. POSITION REQUIREMENTS: 1. Skillset: General a. Excellent written and verbal communication skills b. Strong organizational skills c. Ability to work independently with minimal direct supervision d. Communicate effectively with other CP Kelco employees, the corporate site, and external customers 2. Skillset: Computer a. Good working knowledge of Windows-based computer programs (Word, Excel, Outlook, Adobe, etc.). b. Ability to use computer for research. REQUIRED QUALIFICATIONS: Education/ Work experience Ability to demonstrate skillsets required for effective performance of job functions, duties and responsibilities. PHYSICAL REQUIREMENTS: Office environment. Files management may require moving boxes and files. See end for requirements. Compensation will be determined by experience. Contact Cheryl Van Dyne: cheryl.a.vandyne@cpkelco.com

Beckloff Associates

Director, Pharmaceutical Sciences (4/23/08) Beckloff Associates, a Cardinal Health company, provides a wide range of consulting services required to obtain marketing approval for drugs, biologics, and medical devices in the U.S., Canada, and Europe. Our goal is to help biotechnology, pharmaceutical, and medical device customers with the design and implementation of efficient global scientific and regulatory strategies. Our services include: > Overall drug development and strategic planning > Worldwide scientific regulatory strategies > Preclinical and clinical research programs > Chemistry, manufacturing, and controls (CMC) > Current Good Manufacturing Practices (CGMPs) > Training and education Job Description: Manages a wide variety of assigned client projects involving most aspects of the drug development process (regulatory, clinical, nonclinical, toxicology, etc.), including strategic development, evaluation of scientific information, and scientific and regulatory document preparation and maintenance (IND, NDA, ANDA, BLA, DMF, MAA, Annual Reports, Amendments, Supplements, Investigator’s Brochures, etc.). Provides technical and regulatory guidance and assistance to clients. Interacts directly with clients and contractors as required by projects, including participation in teleconferences and meetings; is instrumental in identification, selection, and management of contractors’ activities on behalf of the client. Interacts with U.S. and foreign regulatory authorities, including providing liaison responsibilities, preparation for, and attendance at formal meetings. Performs compliance audits. Presents regulatory-related lectures at client training programs, as required. Requirements: PhD in pharmaceutics, chemistry, biochemistry, toxicology, or MD, with 10 to 15 years of direct experience in product development. Experience in creating and reviewing regulatory documents and submissions is a must. Experience in interacting with the FDA and other regulatory agencies is highly desirable. Contact: For more information, please contact or send resume to: Carolyn Rynard Beckloff Associates, a Cardinal Health Company 4275 Executive Square, Suite 300 La Jolla, CA 92037 Telephone: 858.535.2430 Facsimile: 858.535.2439 Email: crynard@beckloff.com

Cadence Pharmaceuticals

Director/Senior Director Regulatory Affairs (4/09/08) Cadence Pharmaceuticals is a hospital-focused biopharmaceutical company. We are committed to the development and commercialization of pharmaceuticals to meet the needs of hospitalized patients and their caregivers. Position Summary This position is responsible for the regulatory affairs function and the strategies for regulatory requirements for company product(s). Responsibilities include management of the preparation of regulatory filings and completion of submissions required for INDs, CTAs, NDAs and MAAs. Responsible for developing strategies/timelines, conducting meetings, acting as liaison with regulatory authorities, participating in inspections, budgeting, and presenting project plans to management. Works closely with other functional areas such as Clinical Development, Project Management, Manufacturing, Quality and Marketing. Principal Duties and Responsibilities • Develop, execute and provide guidance for effective, proactive regulatory strategies and plans. • Prepare, review and approve investigational, marketing, and/or post-licensure regulatory submissions (including INDs, IND amendments, annual reports, CTAs, NDAs, NDA supplements, etc) in accordance with the regulations and relevant guidelines (domestic, national and international). • Independently manage the regulatory aspects of complex projects/products, including major applications submitted to regulatory agencies. • Present regulatory strategies to customers as necessary to ensure successful strategy implementation. • Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact Cadence’s products and operations. Advise personnel in other departments regarding their applicability and impact. • Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. • Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies. • Interface with other team leaders to ensure coordination and implementation of consistent standards and processes. • Provide technical writing assistance to authors of submission documents. • Proofread documents and work closely with Regulatory Operations to publish the final regulatory submission. • Support post-marketing activities for commercial products as required, including review and approval of commercial labeling and advertising/promotional materials, based on domestic and international regulatory requirements. • Manage the regulatory aspects of partnerships with CROs and suppliers. Participate in the development of contractual agreements. • Provide guidance and direction to regulatory employees in submission preparation, team participation and coordination. Qualifications • Minimum 10-15 years experience in pharmaceutical industry or equivalent, with a minimum of 8-10 years in Regulatory Affairs. • Bachelors degree; advanced degree preferred. • Proven ability to develop and defend regulatory strategies for projects. • Experience in and a thorough understanding of the preparation of scientifically valid submissions and the translation of regulatory requirements into practical plans. • Demonstrated work experience in all phases of drug registration and approval, from pre- to post-launch. CMC section experience is essential. • Must be able to interpret and apply government regulations. • Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills. • Exceptional cross-functional team leadership skills. • Ability to work in close collaboration with others. • Strong organizational and planning skills, as well as strong attention to detail. • Accountable for results and goal attainment. • Experience with electronic submissions requirements and the review of technical reports prepared in support of regulatory filings. • Ability to work independently with limited supervision, adapt to change and manage multiple tasks. • Ability to problem-solve and make decisions on complex issues, often in a cross-functional team setting. • Technical knowledge of US regulations and ICH and GXP Guidelines. • Strong computer skills in Word, Access and Adobe Acrobat and working knowledge of electronic publishing/file management. Special Working Conditions This position will require periodic travel (up to 40%) in the US and Europe. Please submit resumes to careers@cadencepharm.com. The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Ambit Biosciences

Manager, Quality Assurance (MQA-418) (3/31/08) Ambit Biosciences is engaged in the discovery and development of small-molecule kinase inhibitors for the treatment of cancer. With more than 500 distinct kinases identified and over 30 kinase inhibitors in clinical trials or FDA approved, this important class of proteins is a rich area for therapeutic drug development. Ambit currently has two compounds in early stage clinical development. We are seeking a talented Manager, Quality Assurance to join our Regulatory team. The Manager, Quality Assurance responsibilities will include, but not limited to: • Establishing quality assurance function within company to provide appropriate oversight to support research and development • Managing creation, revision and control of SOPs and other controlled documents and tools to assure adherence to GLP, GMP and GCP regulations • Managing internal and external audits of vendors and clinical sites • Reviewing processes and systems to ensure compliance with study protocols, SOPs and applicable guidelines/regulations and local laws in relation to the conduct of clinical study research. The successful candidate will have the following qualifications: • BS degree in scientific or healthcare discipline • Minimum of five (5) years pharmaceutical industry experience with at least four (4) years in Quality assurance • Working knowledge of GCP, GMP and GLP regulations • Ability to work both independently and within cross-functional project teams • Experience with working in an electronic document management environment highly preferred Interested candidates, please apply directly online at www.ambitbio.com or email resumes to careers@ambitbio.com. Please reference Job Code #: MQA-418

Manager, Regulatory Operations (MRO-417) (3/31//08) Ambit Biosciences is engaged in the discovery and development of small-molecule kinase inhibitors for the treatment of cancer. With more than 500 distinct kinases identified and over 30 kinase inhibitors in clinical trials or FDA approved, this important class of proteins is a rich area for therapeutic drug development. Ambit currently has two compounds in early stage clinical development. We are seeking a talented Manager, Regulatory Operations to join our Regulatory team. The Manager, Regulatory Operations responsibilities will include, but are not limited to: • Establishing regulatory operations function at Ambit • Setting up document management system (electronic and hardcopy) • Preparing, submitting and archiving global regulatory documents, eg, INDs, IND Amendments, Annual Reports, CTAs etc. to support clinical studies • Creating standard templates in accordance with ICH documentation guidelines • Reviewing and editing documents to ensure consistency and regulatory compliance • Representing regulatory on project sub- teams, e.g., CMC, Clinical • Providing ongoing tactical regulatory support for development programs The successful candidate will have the following qualifications: • BS in scientific or healthcare discipline • Minimum of five (5) years pharmaceutical industry experience with at least four (4) years in regulatory affairs. • Ability to work both independently and within cross-functional project teams • Experience with setting up and maintaining electronic document management system • Knowledge of regulatory affairs requirements for oncology drug products highly preferred Interested candidates, please apply directly online at www.ambitbio.com or email resumes to careers@ambitbio.com. Please reference Job Code #: MRO-417

Optimer

Director of Regulatory Affairs (3/04/08) Optimer Pharmaceuticals is looking for an experienced and forward-thinking individual to manage and lead the Company's internal teams and external partners in all aspects of regulatory affairs. The successful candidate will be responsible for regulatory activities related to IND, NDA, NDS, MAA, BLA submissions and related amendments, and key interactions with regulatory authorities and agencies. Knowledge of current FDA, EMEA and ICH regulatory requirements and guidelines is essential. The scope of responsibility spans all global registration efforts. Position Summary The Director of Regulatory Affairs will work closely with R&D, CMC, clinical development, medical affairs, clinical trial CRO and regulatory consultants in the process of defining regulatory requirements and strategies to the final approval and post-approval activities of the new drug application submission. Additionally, this person will review submissions for regulatory compliance and technical accuracy, and will oversee all liaison activities between the company and regulatory agencies. Responsibilities: • Responsible for defining and implementing regulatory strategies, milestones, and procedures. Provide regulatory strategy for IND, NDA, CTA, IMPD, NDS, MAA, BLA, etc. filings and associated meetings with regulatory authorities. • Act as or manage FDA liaison and liaison to Ex-US Health Authorities. Responsible for the preparation for key meetings with the FDA and other regulatory authorities. • Prepare FDA and international submissions including IND, CTA, NDA/CTD, SNDAs, IMPD, NDS, MAA, BLA amendments, supplements, variations, responses to Agency questions, meeting requests, briefing packages, annual reports, and periodic safety reports, etc. • Develop and implement policies and procedures to ensure compliance with FDA and other international regulatory agency rules as required. • Participate in clinical regulatory strategic planning. Assist with preparation of clinical trial documentation such as Investigator's Brochures, protocols/amendments, and related reports, presentations, and press releases, etc. • Provide regulatory input and guidance on product pre- and post launch activities, including new indications and claims (e.g. clinical trial protocols, filing requirements, labeling, and promotional items). • Participate in clinical trial CRO and RiskMap management. • Act as regulatory representative on Product Development Teams. • Budget planning and management. • Project timeline planning and management including recruiting as required. Educational/Skill Requirements • Minimum of BS degree + 10 yrs exp or MS degree + 7 yrs exp in regulatory affairs. Infectious disease experience preferred. • Extensive knowledge of and hands-on experience with the preparation of critical regulatory submissions (all IND, NDS, MAA, BLA and NDA phases), supportive amendments and supplements. • A track record of achievement in regulatory affairs in the domestic and international market sectors. Demonstrated excellence in designing and executing successful regulatory strategies. • High energy level candidate successful in the management of timelines and milestone achievement. Team-building management style with solid mentoring and counseling skills. • A strategic thinker with the ability to parallel process across the product profile. • Strong analytical, effective data handling skills and being decisive are highly desired. • Excellent communication skills – written and verbal, and solid presentation skills. • Strong personal and professional ethics. Interested candidates fax or e-mail resume: Attn: HR, 858-777-3468(fax) or careers@optimerpharma.com About Optimer Pharmaceuticals Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer has two late-stage anti-infective product candidates. OPT 80, currently in two pivotal Phase 3 clinical trials, is being developed for the treatment of Clostridium difficile-associated diarrhea, the most common hospital-acquired diarrhea. Prulifloxacin, also in two pivotal Phase 3 clinical trials, is an antibiotic being developed for the treatment of travelers' diarrhea, a form of infectious diarrhea. Additional information regarding Optimer can be found at http://www.optimerpharma.com.

Halozyme

Publication Specialist - Regulatory Affairs/Quality Assurance (2/25/08) Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular matrix for the drug delivery, oncology, and dermatology markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets. In addition, the company has received FDA approval for two products: Cumulase® and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter Healthcare Corporation. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need. The company seeks an outstanding individual as the Publication Specialist – RA/QA who will be responsible for providing expert technical guidance within RA/QA and to other functional areas on electronic regulatory submissions. This individual will compile and release electronic and, as appropriate, paper submissions to regulatory agencies. ESSENTIAL FUNCTIONS AND RESPONIBILITES: These include, but are not limited to: • Compiles and releases submissions to regulatory agencies as follows: Investigation New Drug Applications (IND) New Drug Applications (NDA) IND/NDA Supplements IND/NDA Annual Reports Periodic Safety Update Reports Drug Master Files Adverse Event Reports Marketing Authorization Requests Request for Designations Medical Device Pre-market Application (PMA) PMA Annual Reports CE Technical Files • Works with a high degree of independence as the lead RA/QA representative on electronic systems implementation and operations. • Ensures that all aspects of electronic submissions meet regulatory agency and Halozyme’s submission standards and technical requirements. • Supports the electronic archiving and reporting for product complaints, adverse events, safety databases, and other depositories as necessary. • Supports product quality tracking and reporting for management reviews. ADDITIONAL FUNCTIONS AND RESPONSIBILTIES: • Performs other duties as assigned. EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED: • Ideally a BS or BA in a scientific field with 2 years experience in the pharmaceutical, device, diagnostic or medical field • ICH eCTD experience • Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents • Knowledge of GMP’s, GLP’s and GCP’s is desirable • Good writing and verbal communication skills. • Ability to work independently • Ability to work in team environments • Good problem solving skills • Ability to multitask and work within a fast-paced dynamic team environment TECHNICAL KNOWLEDGE: Equipment: A working knowledge of PCs, scanners, facsimile machine, voice and e-mail systems, and common office machines is also required. Knowledge of other equipment required: Software Knowledge: Windows, MS Office (Outlook, Word, Excel), Adobe, XML and SML authoring tools, ISI Toolbox, eCTD Software, Pilgrim Software, SAS file formats, Prizm, Octagon Viewpoint INTERNAL AND EXTERNAL RELATIONSHIPS: • Reports to the Associate Director, Regulatory Affairs and Quality Assurance EFFORT REQUIRED: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. TRAVEL: Limited travel may be required up to 5% of your time At Halozyme, we provide a stimulating, entrepreneurial work environment, competitive compensation including equity participation, and an excellent benefits package To apply for this position, please send your resume to hr@halozyme.com and reference job code 801-MEW-PS-SDRAN For more information on the company, visit our website at www.halozyme.com Stock Symbol: HALO EOE.

Metabasis Therapeutics, Inc.

Associate Director, Quality Assurance - Job Code #08-009 (2/08/08) This position will develop, coordinate, and implement FDA regulated quality programs required for a pharmaceutical development organization, and provide guidance necessary to maintain compliance to applicable regulations (e.g., GMP, GLP, and GCP). The individual will manage quality assurance activities supporting the manufacture of active pharmaceutical ingredients and drug product at contract manufacturing organizations, and the activities supporting release and stability testing of same at contract testing facilities. Specific duties include: • Providing oversight of contract manufacturers, testing laboratories, packaging/distribution/storage facilities • Participating in the evaluation, qualification and auditing of contract organizations • Reviewing records and data associated with clinical trial materials, and disposition for use • Reviewing records and data associated with GLP activities • Serving as a member of the QAU in support of internal GLP activities • Designing and implementing training programs • Assisting in the development, implementation and maintenance of the MTI Quality Systems • Interpreting, and educating organization on, regulations/standards • Developing and implementing corrections/efficiencies Qualified candidates will possess: • BS in related field, and 8-12 years related experience in FDA regulated pharmaceutical and/or biotech industry, with a minimum of 8 years in a Quality Assurance function. • Comprehensive and up-to-date knowledge of and experience with cGMP and GLP requirements, familiarity with GCP requirements and FDA and EU regulations and applicable regulatory guidance documents • Ability to work successfully with multinational, interdisciplinary project teams and proven ability to influence and collaborate effectively • Working knowledge of drug development processes, analytics • Ability to plan and coordinate activities simultaneously on multiple projects under pressure of time and workload • Excellent attention to detail without losing sight of overall goal Metabasis Therapeutics, Inc. is a San Diego-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies to address some of the world's most widespread and costly chronic diseases. Metabasis has a broad product pipeline targeting large markets with significant unmet medical needs. We are specifically focused on metabolic diseases involving pathways to the liver, such as diabetes and hyperlipidemia, as well as liver diseases such as hepatitis and liver cancer. We currently have five internally discovered product candidates in clinical development as well as an active discovery team seeking additional product candidates to treat metabolic diseases. Metabasis Therapeutics is an equal opportunity employer offering a competitive compensation package including a stock option program & comprehensive benefits, in a fast-paced, highly stimulating, team-oriented environment. Qualified applicants are invited to submit a resume and cover letter to: Metabasis Therapeutics, Inc. Human Resources Dept. 11119 North Torrey Pines Road La Jolla, CA 92037 Fax: (858) 458-3504 jobs@mbasis.com www.mbasis.com