January Event: 2021 Annual Meeting and January Program
Register Here Join us for a brief 2020 SDRAN recap followed by a presentation entitled: FDA Feedback from Recent Biocompatibility Submissions Wednesday, January 20, 2021 FLYER Event Agenda: Date: Wednesday, 20 January 2021 Time*: 6:00 – 6.05 PM – Welcome - Erica Livingston & Sasi Mudumba 6:05 – 6.30 PM – Annual Meeting 6:30 – 7.30 PM – Program Presentation 7:30 – 7:45 PM – Q & A
*Times are approximate. Speaker: Thor S. Rollins Director, Toxicology and E&L Consulting Nelson Laboratories, LLC Program Topic: Nelson Labs has a great deal of experience performing biocompatibility and extractable and leachable (E&L) studies for regulatory submissions - including the US FDA. With this experience, Nelson Labs has followed FDA feedback trends on recent submissions and developed specific procedures to address this feedback. In this presentation, Thor will cover the recent FDA biocompatibility and E&L feedback and concerns and will discuss approaches to address these concerns before the submission process. Speaker Biography: Thor Rollins is a certified microbiologist who specializes in the selection and execution of in vitro and in vivo biocompatibility tests. Currently he is the Director, Toxicology and E&L Consulting at Nelson Laboratories, LLC. He actively speaks on biocompatibility related topics through external seminars, webinars, conferences, and trade shows. Thor has published multiple peer-reviewed articles and white papers regarding the proper testing of medical devices. Thor is a participating member of all AAMI (Association for Advancement of Medical Instrumentation) TC 194 and ISO 10993 committees. He plays an active role with the FDA and other regulatory committees in developing standards concerning biocompatibility methods; he is also a voting member regarding changes to those standards. As one of a select group of experts in the industry, Thor's participation on these committees offers him unique insight into industry changes which he uses to help prepare clients for changes in testing. Location: Not applicable - This is an online event Online registration (ends 19Jan2021):
$10 SDRAN Member $15 Non-Member For Questions Email:
Company Name: Hologic Job Location: San Diego, CA Position Title: Senior Clinical Compliance Specialist Position Type: Full time Responsibilities: • Maintains and contributes to a Clinical Quality Management System to ensure San Diego Clinical Affairs (CA) activities are carried out in accordance with current applicable company policies and procedures, and laws, regulations, and guidelines • Researches and summarizes knowledge and information on current regulations, guidance, best practices relevant to Hologic Diagnostic products and clinical studies; publishes and presents assessments and findings to stakeholders • Hosts internal Quality Assurance (QA) audits of CA, and supports audits and inspections of Hologic conducted by external regulatory entities (e.g., US FDA Bioresearch Monitoring (BIMO), Notified Bodies (NB)) • Conducts audits of clinical studies at external sites and in-house • Conducts review and change control of CA documents and procedures in the Quality System Manual and in department-specific libraries • Oversees and manages CA department and corporate policy and procedure training requirements • Supports CA personnel on use of corporate and department systems used for creating, editing and storing documents and information; curates documents and information to ensure relevancy and contemporaneousness • Provides support to clinical study projects and functions as needed • Keep current in IVD Clinical, Regulatory and Quality trends and intelligence by conducting relevant research online and by attending forums. Write summaries to provide relevant information to stakeholders as requested. Share and curate relevant information on CA Intranet • Support CA as a subject matter expert (SME) in audits of CA by meeting with auditors and providing documentation and information • Conduct periodic audits of Trial Master Files (TMFs) in-house; audit external clinical study sites as assigned by study management. Write detailed reports and communicate findings • Conduct change control activities for all Clinical Affairs documents in Agile Product Lifecycle Management (PLM) environment, and in the SharePoint Clinical Documents library • Champion department and corporate training for Clinical Affairs; ensure department and corporate training requirements are kept current; identify gaps. Act as department Superuser of corporate training system Qualifications: • Strong knowledge of US and EU regulations relevant to Medical Device and IVD clinical trials and Quality Systems, including GCP • Excellent technical writing and presentation skills • Advanced user of Microsoft Office (Word, Excel, PowerPoint) and Visio a plus; experience using Microsoft SharePoint a plus • Education • Minimum BA/BS degree in Life Sciences or equivalent qualification • Advanced degree or professional certification in Clinical, Regulatory and/or Quality (e.g., RAC, CCRA/CCRP, RQAP-GCP) is highly preferred Education and Experience • 8-10 years of progressive experience in clinical research within a regulated industrial setting. Experience in an IVD environment is highly preferred • Reading, interpreting, and summarizing regulations, guidelines, best practices relevant to clinical research • Writing and editing summary documents, procedures, protocols, or other technical documents, and presenting to stakeholders at all levels • Hosting audits and conducting in-house and external site audits. GCP audit experience preferred • Experience auditing documents and processes • Use of change management concepts and software, and Microsoft Office tools Application Information & Contact (How to Apply) Please apply here. Learn more about Hologic here.
Company Name: ICUmedical Job Location: San Diego, CA Position Title: Senior Associate, Regulatory Affairs - Device Position Type: Full time General Job Description: Provides regulatory support and expertise associated with global and US registration of device products (safety software portfolio), including in-depth analysis of the requirements and tracking of deliverables. With oversight, supports creation of global regulatory strategies and assists in execution including creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management. Responsibilities: Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations. Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines. With oversight, serves as a liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings. Evaluates manufacturing and labeling changes for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review. Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review. Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team. Qualifications: Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission. Identify registration documentation deficiencies and work with colleagues to accomplish resolution. Interpret global regulations and assure regulatory compliance, minimizing development costs and cycles. Define and negotiate regulatory strategy with supervision. Exercise good judgment within policy and regulations. Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters. Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues. Presents scientific data effectively orally and in writing in a logical and persuasive manner. Provides daily regulatory support to new product development teams and commercial support with guidance. Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution. Acts independently on all routine issues, makes judgment and executes. Education and Experience Bachelor’s Degree preferred in pharmacy, biology, chemistry, pharmacology, engineering or related subject. Master’s Degree or P.H.D preferred RAC Certification preferred Minimum of 3 years of experience in Regulatory Affairs, Research, Development or related area. Able to follow scientific arguments. Good interpersonal skills. Good oral and written communications skills. Developing negotiating skills. Developing understanding of business needs. Minimum Qualifications Must be at least 18 years of age Must pass pre-employment drug screen and background check Travel Requirements Typically requires travel 5-20% of the time Physical Requirements and Work Environment This is largely a sedentary role. This job operates in a professional office environment and routinely uses standard office equipment. Work is performed in a clean room environment While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating Operator is required to use computer or touch screen to enter work order data Must be able to occasionally move and lift objects of up to 25 lbs We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity. Application Information & Contact (How to Apply) Please apply here. Learn more about ICUMedical here.
Register Here Member Appreciation Event: CSI MURDER MYSTERY Wednesday, December 02, 2020 FLYER Event Agenda: Date: Wednesday, 02 December 2020 Time*: 6:00 – 8:00 PM Member Appreciate Event (ONLINE)
*Times are approximate. For a special member appreciation event this year, please join us on Wednesday, 02 December 2020 at 6:00pm for a night of fun with our virtual CSI murder mystery team building experience! For 2 hours, be part of a Crime Investigation team and attempt to solve a double homicide. You will be teaming up with a CSI expert and conducting suspect interrogations, working with recreations of murders and events, and an off-site crime scene evidence lab. Will you have what it takes to solve this murder? Please make your reservation early for this annual Members Only event! Registration is capped at 100. Location: Not applicable - This is an online event Online registration (ends 28Nov2020):
Register Here The New Roaring 20s and Advances in Gene Therapy Drug Development Wednesday, November 18, 2020 FLYER Event Agenda: Date: Wednesday, 18 November 2020 Time*: 6:00 – 6:05 PM Welcome and Announcements (ONLINE) 6:05 – 7:05 PM Program Presentation (ONLINE) 7:05 – 7:30 PM Q & A (ONLINE)
*Times are approximate. Speaker: Amanda Richter Executive Director, Regulatory Affairs Neurocrine Biosciences, San Diego, CA. Program Topic: After nearly 40 years of gene therapy research, we have finally entered an age of realization for patient treatments. Recent years have seen approved gene therapies in Europe and the US, and an explosion of clinical trials is underway. This presentation will provide an overview of gene therapy drug development for those interested in learning about development and licensure of gene therapy products. Intended for learners at all levels, the speaker will touch on case studies of approved therapies and challenges along the way to licensure. Speaker Biography: Amanda Richter is a regulatory drug development expert with more than 20 years of experience in research and development of medical products, including 16 years of experience in Regulatory Affairs. She has expertise in small molecules and biologics, with a focus on rare disease development. For the past 10 years, Amanda has worked in the field of gene therapy drug development. She joined Neurocrine in January 2020, where she serves as the regulatory lead for gene therapy programs under development in CNS diseases, including a Parkinson’s disease program which has received RMAT designation. Prior to Neurocrine, Amanda worked at Tocagen for 9 years, where she led the regulatory development of the company’s gene therapy programs, one of which received Orphan Drug designation from FDA and EMA, as well as Fast Track, Breakthrough Therapy, and PRIME designations for recurrent high grade glioma. She has previously held positions at Biogen Idec, Ambit Biosciences Corp, Santarus Inc, and Integra Lifesciences. Amanda holds a Master of Science in Regulatory Affairs from the San Diego State University, and a Bachelor of Science in Microbiology from the University of California, Davis. She is Regulatory Affairs Certified (RAC, US and EU) since 2005, and is a member of SDRAN, RAPS, and TOPRA. Location: Not applicable - This is an online event Online registration (ends 17Nov2020):
$10 SDRAN Member $10 Non-Member For Questions Email:
Company Name: Clarity Technology Partners Job Location: Carlsbad, CA Position Title: Sr. Regulatory Affairs Specialist Position Type: Full time General Job Description: We are looking for a Sr. Regulatory Affairs Specialist in Carlsbad, CA for our client in the dental industry. We have placed a number of candidates with this client and it is a great place to work, truly one of the leaders in their field! This is a full time, permanent role that comes with great benefits including medical/vision/dental insurance, PTO, 401k, etc. This role will be remote for the time being, but likely to transition to onsite in the future. As the Sr. Regulatory Affairs Specialist you will participate and manage necessary regulatory and project management activities required for medical device registration and compliance, with a focus on European Medical Device registration. Essential Job Duties and Responsibilities: Plan and prepare global regulatory dossiers with a focus on Medical Device Technical Files in accordance with MDD and MDR. Assist the Regulatory Affairs Director with Regulatory activities to ensure compliance with the new European Medical Device Regulations (MDR). Ensure compliance with US and international regulations and guidelines. You will also provide routine regulatory support, which may include, but not limited to: Support the compilation, development, submission, and maintenance of worldwide regulatory filings -Track regulatory project status and informational documents -Create timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time -Interface with global Regulatory partners and internal cross functional teams -Attend relevant functional area and project team meetings as required. Responsibilities: Plan and prepare global regulatory dossiers with a focus on Medical Device Technical Files in accordance with MDD and MDR. Assist the Regulatory Affairs Director with Regulatory activities to ensure compliance with the new European Medical Device Regulations (MDR). Ensure compliance with US and international regulations and guidelines. Qualifications: Must have experience with European Regulations around Medical Devices. Ideally experience with EU Medical Device Directives (MDD) or EU Medical Device Regulations (MDR). Must have experience in creating technical files as this is a part of the European registration process. Application Information & Contact (How to Apply) Please apply to our Linkedin job posting, or email your resume directly to Learn more about Clarity Technology Partners here.
Register Here Monthly Program event co-organized by SDRAN and OCRA GCP COMPLIANCE and FDA BIMO INSPECTION READINESS Wednesday, October 21, 2020 FLYER Event Agenda: Date: Wednesday, 21 October 2020 Time*: 6:00 – 6:05 PM Welcome and Announcements (ONLINE) 6:05 – 7:05 PM Program Presentation (ONLINE) 7:05 – 7:30 PM Q & A (ONLINE)
*Times are approximate. Speaker: Tommi Papson Former FDA Investigator and President and Co-founder of Regulatory Consultants Group Jacqueline Bushong Sr. Director, Head of GCP Quality Assurance at Kiniksa Pharmaceuticals in La Jolla, CA Program Topic: No matter if your company is a Sponsor or Clinical Research Organization, large or small, brick and mortar or virtual, we all need to be ready for regulatory inspections. Ideally, quality is built into the culture and processes where you work, & getting ready for an inspection is fairly easy. But with competing priorities, external competition, rushing to meet corporate deadlines, and a need for speed even a Quality Culture can suffer some setbacks from cutting corners, too much work, and too few resources. Compliance is challenging and getting ready for inspection can be fraught with stress and worry. Take a deep breath and learn how to simplify your activities, manage timelines, and have everything ready for that BIMO inspection of a recent regulatory submission. Speaker Biography: Tommi Papson, former FDA investigator and Jacqueline Bushong, Sponsor Representative, have experience preparing companies for and participating in regulatory inspections (albeit from opposite perspectives). Jacqueline Bushong is the Sr. Director, Head of GCP Quality Assurance at Kiniksa Pharmaceuticals in La Jolla, CA. She has 20+ years of experience in the pharmaceutical / biotech industry at various companies, both large and small. Jackie has experience in large and small molecule therapies, including T-Cell immunotherapies. Her experience includes directing CQA department activities, managing Clinical and Pre-clinical QA staff and compliance programs, performing risk assessments, planning and executing inspection readiness activities, and conducting routine and for-cause audits of clinical investigator sites, internal systems, and a wide variety of service providers. She also serves as President of Pacific Regional Chapter of Society of Quality Assurance (PRCSQA). Jackie graduated from Upsala College in East Orange, NJ with a Bachelor of Science degree in Chemistry. She lives in Southern California with her spouse, 3 chinchillas, and her 2 SPOOS (standard poodles), Gabriel and Mercedes. Tommi Papson is the President and Co-founder of Regulatory Consultants Group. As a former FDA Investigator, Tommi, known for the “Knock Knock, the FDA is Here” training and experiences of do’s and don’ts with the Regulator shares the fun and excitement of getting a “483” and warning letter. Over two decades of experience in the BIMO, Medical Device and Pharma regulatory environment, International Cadre, and Recall Coordinator, now provides support to companies regulated by FDA and global regulatory bodies. Tommi is President Elect of Orange County Regulatory Affairs (OCRA) Worked with DOJ, FBI and Office of Criminal Investigations on investigations and prosecution of recalcitrant firms, and now help firms not to be on Breaking News. Tommi enjoys painting, traveling with a spouse that loves to hear “back up did you see that”, as the Photographer captures another cloud, or barn, or flower along the journeys of life. Location: Not applicable - This is an online event Online registration (ends 20Oct2020):
$10 SDRAN Member $10 Non-Member For Questions Email:
Company Name: Aurora Spine Job Location: Carlsbad, CA Position Title: Manager of RA/QA Position Type: Full time General Job Description: Function as the Company’s Management Representative. Fully implement the quality management system and ensure that the Company is in compliance with ‘Regulations’ (I.e., QSR, CMDR and MDSAP), ‘Standards’ (I.e., ISO 13485) and the Quality Manual. Application Information & Contact (How to Apply) Cover Letter and Resume to Learn more about Aurora Spine here.
Company Name: Samorn Biosciences Job Location: San Diego, CA Position Title: Senior Medical Writer Contractor Position Type: Contract General Job Description: Samorn Biosciences is looking for a Senior Medical Writing Contractor who has scientific knowledge and writing expertise to effectively communicate technical, pharmaceutical, drug, and scientific medical information. Document audiences include regulatory authorities, clinical study sites, and thought leaders involved in drug, drug-device, and biologic development. The position’s focus includes clinical documents such as protocol and clinical study reports (CSRs), and regulatory submissions. This will entail some project management and leadership, working closely with internal and client team members to ensure the documents are high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, eCTD requirements and company goals. The core responsibilities of the Senior Medical Writer, Development are listed below. Responsibilities: Write, edit and collaborate on development of preclinical, clinical, and sections of regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, DSURs, INDs, eCTD/NDA modules, clinical summaries, briefing books) Compile, write, and edit documents covering all phases of clinical research, to include integrated summaries of data, risk/benefit analysis, etc Assist in the analysis, synthesis and presentation of complex information for scientific presentations Distill large amounts of clinical and scientific data into essential elements for graphical display. Formulate key messages from clinical study data Perform literature-based research to support writing activities Provide QC review support as needed and ensure consistency between related documents Understand the levels of evidence required to achieve regulatory and clinical trial goals. Ability to coordinate, plan, and manage communications to enable timely review from other authors and reviewers and to function as a collaborative team member Create and maintain document timelines incorporating client team input Develop and maintain medical writing processes, SOPs, templates, and outlines for key documents Maintain an awareness of current industry practices and regulatory requirements that affect medical writing Keep abreast of current literature, emerging science, technological developments, and medical trends Qualifications: BS, MS, PharmD, or PhD in a scientific or medical discipline with relevant experience 5+ years’ experience in the clinical/regulatory writing and editing Basic to intermediate knowledge of biostatistical and clinical research concepts Thorough understanding of FDA and ICH regulations and guidelines, and AMA editing standards Experience authoring/editing CSRs and other types of clinical regulatory documents (e.g., clinical protocols, Investigator’s Brochures, NDA modules) Proven ability to implement medical writing processes and standards Knowledge of Microsoft Office applications, document templates, and electronic document management systems; proficiency in Word, Excel, PowerPoint, email, and the Internet Willingness and ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment; adapts to changing deadlines and priorities Ability to work collaboratively to coordinate the efforts of team members to complete deliverables Exceptional oral and written communication skills Flexible, adapts work style to meet organization needs Motivated, self-directed and able to work autonomously and in team settings to meet aggressive organizational goals Available writing samples for Samorn Biosciences review Application Information & Contact (How to Apply) Please email your resume to email@example.com Learn more about Samorn Biosciences here.
21st OCRA Annual Meeting: 2020 VISION October 6, 2020 - October 7, 2020 8:00 AM - 1:00 PM PST Register Here We will be hosting a number of FDA speakers and industry thought leaders. The 2020 Annual event webpage is open for business. Please check it out! Speakers: Pharma: Alonza Cruse, Director, Office of Pharmaceutical Quality Operations FDA/ORA Medical Devices: Shari Shambaugh, Program Division Director, Office of Medical Device and Radiological Health Operations (OMDRHO) BIMO: Eric Pittman, Program Division Director Bioresearch Monitoring Program Division II West Compliance: Keith Hadley, Special Agent, Office of Criminal Investigations, US FDA Please forward invite to colleagues and friends from other organizations who may be interested .
Regulatory Medical Writing Lead (positions up to Director considered)
Company Name: Aroga Biosciences Job Location: San Diego, CA Position Title: Regulatory Medical Writing Lead (positions up to Director considered) Position Type: Full time General Job Description: Aroga Biosciences is a boutique firm that provides highly experienced regulatory writing services for biotech and pharmaceutical projects. We are a team of scientists with extensive regulatory and medical writing experience in a broad range of therapeutic areas. Our mission is to provide high-quality deliverables with flexibility and adherence to regulatory standards. We are looking for a candidate to join our growing team of talented regulatory medical writers. Responsibilities: The regulatory medical writer will lead document development of CSRs, IBs, nonclinical summaries, protocols, and regulatory documents. May include management and mentorship of other writers depending on experience. The candidate should have strong communication and project management skills. Qualifications: Medical writing experience required; M.S., Ph.D, PharmD, MD/DO preferred Application Information & Contact (How to Apply) Please email resume/CV to Learn more about Aroga Biosciences here. Check out the Aroga Biosciences LinkedIn page here
Company Name: Neurelis Job Location: San Diego, CA Position Title: Director or Senior Director, Quality Assurance Position Type: Full time General Job Description: Neurelis is a neuroscience-based specialty pharmaceutical company providing innovative approaches to target unmet medical needs. Our approach combines novel technologies designed to enhance therapeutic benefit and address unmet needs in patient care. Neurelis offers competitive pay and benefits and a collaborative and growing team who are passionate about their products and company. We may be small but we are mighty! Reporting to the Senior Vice President, Regulatory Affairs and Quality Assurance, the Director or Senior Director, Quality Assurance will be responsible for leading the strategy, implementation, and leadership of the Quality Assurance function at Neurelis. This includes leading the execution and administration of the GxP quality systems to support GMP, GLP, GCP, GPvP and GDP compliance in accordance with US, ICH and EU regulations. The Director or Senior Director, Quality Assurance will establish quality systems, create, administer and manage SOPs, and oversee field-based consultants. Responsibilities: Ensures quality and compliance oversight for manufacturing, supply chain and distribution, nonclinical, clinical and IT systems that support the developmental programs and commercial portfolio of Neurelis. Manages compliance to and of the Neurelis quality systems. Provides quality oversight of external vendors (CMOs, CROs, suppliers, etc.) and ensures adherence to Neurelis' vendor qualification criteria. Establishes an annual audit plan and conducts external audits of vendors. Responsible for managing the product complaints process, including handling escalated complaints, conducting investigations, and managing records. Participates in batch record review and approval, and ensures that copies of all manufacturing batch records are archived. Establishes product verification and suspicious order monitoring programs. Qualifications: Competencies: Ability to work with and influence others in a multi-disciplinary environment. Provide leadership as well hands-on support in managing, planning, coordinating, preparing and reviewing documents that will be part of the Neurelis quality system. Ability to manage indirect reports, including field-based consultants and vendors. Excellent interpersonal and communication skills. Agile mindset, ability to embrace change, and able to lead successfully during environmental and/ or objective ambiguity. Willing and able to contribute in a hands-on manner. Ability to travel up to 20% (within COVID-19 guidelines). Knowledge/skills: Minimum BS degree (MS degree is preferred) in relevant chemistry or life science discipline. Minimum of 10 years of experience in quality functions, with a history of increasing responsibility. Experience with EDMS for quality systems. Extensive experience in managing GMP activities, preparing for and leading regulatory inspections. Experience working in a small company environment is preferred. Working knowledge of Veeva Vault systems is preferred All recruiting, hiring, training, promotion, compensation, and other employment-related programs at Neurelis are provided fairly to all persons on an equal opportunity basis without regard to race, creed, color, religion, sex, age, national origin, disability, veteran status, or any other characteristic protected by law; Employment decisions are based on the principles of equal opportunity and affirmative action; and All personnel actions such as compensation, benefits, transfers and training are administered without regard to race, creed, color, sex, age, national origin, disability, veteran status, or any other characteristic protected by law. Neurelis is an Equal Opportunity Employer. Application Information & Contact (How to Apply) Please email resume/ CV to Learn more about Neurelis here.