Conventus BioMedical Solutions, Inc.
5414 Oberlin Drive, Suite 130, San Diego, CA
Regulatory Operations Manager
Competitive benefits, matching 401(k), generous PTO policy
General Job Description:
CONVENTUS BIOMEDICAL SOLUTIONS, INC. is a privately-held contract regulatory organization specializing in development solutions and global regulatory strategies and submissions for investigational medicinal products in all phases of development and commercial distribution. Operating with steady growth for over 12 years, the Conventus team has long term multinational client relationships. Conventus develops and maintains regulatory applications for development stage products, and provides regulatory leadership, and develops regulatory submissions for multiple Phase III, pre-commercial and marketed projects.
Conventus team members gain broad and deep experience in multiple aspects of Regulatory Affairs. Our team includes full-time in-house expert personnel, regulatory publishing, and expert affiliates with deep expertise in multiple technical disciplines of product development, who together comprise an integrated team with successful experience in a broad range of therapeutic areas.
Responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with agency requirements and company standards. Acts as direct liaison with Regulatory Affairs staff and contributing departments to facilitate effective management of submissions.
Assures completeness and quality of submissions from the operations perspective. Identifies issues, suggests and implements solutions under guidance.
Sets priorities within area of purview and ensures adequate workload balance through interactions with other team leads and management.
Leads or participates on project teams as appropriate for assigned projects and/or submissions. Implements submission strategies. Maintains submission-planning schedule. Provides coaching/mentoring to Regulatory Operations staff.
Serve as Regulatory Operations project team leader, collaborating with Regulatory Affairs staff and contributing functional areas to assure adequate prioritization, scheduling, preparation and dispatch of regulatory submissions
Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within time lines
Provide accurate regulatory operations guidance and information to project and submission teams. Provide advice on regulatory acceptability of submission plans
Work with Regulatory Affairs managers to identify and allocate resources across projects to ensure timely submissions. Coordinate with counterparts as well as contributing functional areas in establishing project plans. Assist in establishing timelines and ensure that operationally the timelines are met
Prepare interpretative analyses of key regulatory guidance documents related to submissions. Interpret local and U.S. electronic submissions regulations. Develop and implement submission strategies (from operations perspective). Develop templates, processes and procedures to ensure compliance with regulation
Develops and administers in-house training, as needed, to ensure optimal use of templates, processes and tools critical to compiling electronic submission
Advise and direct evaluation, selection, and implementation of technology and equipment related to submission planning, preparation, assembly, dispatch and/or archiving
Serves as primary point of contact for electronic document management (EDM) and publishing systems within Regulatory site. Manages EDM within area of purview and supports processes for compiling electronic submissions U.S
Analyzes and seeks to optimize use of electronic systems and reports
Manage projects with vendors and contractors to meet schedules and ensure quality
Provide coaching and mentoring as needed to more junior Regulatory Operations staff
Provide support in software validation/migration/updates specific to Regulatory affairs
Lead or assist with other projects and activities (appropriate for this job level) as assigned by management, in support of the Regulatory Operations function
As Manager of staff or as Individual Contributor, the incumbent is responsible for:
Organize and maintain submission components associated with a regulatory submission, paper and/or electronic, as required. This may include, but not exclusive to, setting up templates, scanning, printing, and indexing
For assigned projects, responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, production (paper and electronic), and archiving (paper and electronic), as applicable
Routinely exercises problem-solving abilities and makes proper decisions to ensure high-quality and timely delivery of regulatory submissions
Makes decisions and recommendations on operational strategies for effective submissions
Makes decisions in response to internal inquiries regarding regulatory requirements for submission preparation, assembly and dispatch
Makes or participates in decisions on how to manage workload across submission teams and recommends proposed strategies and/or responses to management
Leads project teams as required in developing recommendations and executing solutions in the areas of document management and information technology
Sets procedures for consistent use of technology and regulatory systems used in submissions management and publishing / production
Bachelor’s degree or higher in a relevant technical or scientific field is required
5 years of experience with regulatory submissions and project coordination is required
5 years of experience with processes and standards, regulatory technology (including publishing software), and document management is required
Working knowledge of Agency regulations and industry standards pertaining to regulatory operations is essential
Demonstrated understanding of the drug development process is highly preferred
5 years of staff management or project management experience is highly preferred
Demonstrated accomplishments may be evaluated and substituted for extent of experience, when applicable
Key Skills and Competencies
Must be able and willing to work in a high-visibility, fast-paced environment while handling multiple priorities. Must be flexible, detail-oriented, and possess excellent analytical and problem-solving skills
Shows strong initiative and drive. Must be an organized self-starter who is able to anticipate departmental needs
Proficient in establishing priorities, and setting and executing project plans
Ability to solve problems independently
Knowledgeable in U.S. CTD/eCTD structure and requirements as well as submission requirements for all submission types in applicable region(s)
Experience with electronic document management software (e.g. Documentum), principles of information systems, and related technology, is required
Advanced skills in MS Word, MS Excel, MS PowerPoint, and Adobe Acrobat are required
Experienced with electronic publishing software and advanced PDF processing tools
Experienced with records and/or document management standards
Excellent interpersonal and communication skills are essential. Ability to work successfully within a cross-functional team
Must be able to interact, communicate and present technical information to individuals at all levels of the organization
Skilled in self-development and competent in establishing goals and objectives for self and supervised staff (if any)
Familiarity with MS Project, MS Visio applications, and XML and SQL specifications is preferred
Application Information & Contact (How to Apply)
To apply, email resume to email@example.com