Vice President, Regulatory Affairs
Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.
The Vice President, Regulatory Affairs reports to the Senior Vice President and Chief Medical Officer. The position is responsible for establishing the global regulatory strategy for the company’s product pipeline. This position will provide strategic leadership to oversee and direct all regulatory activities, including developing and implementing strategies for investigational product development through post-approval activities to ensure achievement of business objectives. Select, develop, and evaluate personnel to ensure the efficient operation of the regulatory team. Provide guidance to and manage the regulatory team across regulatory specialties including regulatory CMC, regulatory advertising and promotional review, regulatory clinical support, regulatory operations and regulatory compliance. Provide expertise in translating regulatory requirements into practical and workable plans. Interface with outside regulatory agencies, corporate partners and vendors to develop regulatory and registration strategies. This individual will maintain knowledge and awareness of the global regulatory environment and assess and communicate any changes or impact to the business or development programs.
This role can be remote.
- Provide strategic leadership to develop the regulatory strategy, agency interface and regulatory submissions for products in development as well as approved products.
- Build and lead a team of regulatory staff and consultants supporting Dynavax products.
- Provide leadership, direction and interpretation of FDA and other regulatory agency guidelines to senior leadership and project teams.
- Build a strong relationship and partnership with the FDA and other global health authorities.
- Prepare regulatory submissions, documents and dossiers to support product commercialization. Serve as the final sign-off of regulatory submissions.
- Provide strategic input to target labeling content (SmPC, US package insert, etc.).
- Provide strategic input to product lifecycle issues.
- Lead meetings with regulatory authorities.
- Provide regulatory due-diligence support for partnering and licensing activities.
- Provide regulatory review of press releases, external communications, and scientific publication (Scientific Review Board), as appropriate.
- Oversee regulatory reviewer for advertising and promotional or non-promotional materials through the Materials Review Board (MRB).
- Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.
- Other duties as assigned.
- BA/BS degree required in health and life science with 15+ years of regulatory affairs experience – 8 years in a management role with lead regulatory responsibilities, Master’s degree preferred with 8+ years’ regulatory management experience in the pharmaceutical industry
- Preference will be given to candidates with regulatory experience in v
- In-depth understanding of US and European drug and biologic regulations and guidelines, particularly clinical development and CMC.
- Previous experience working with CDER and/or CBER, some DDMAC or APLB exposure desirable.
- Experience and knowledge in the design, writing and submission of major regulatory submissions and supportive amendments and supplements.
- Proven experience with successful interface/interaction with relevant regulatory authorities.
- Collaborative and team-oriented to foster effective and positive interactions across functions, project teams, regulatory agencies, and corporate partners.
- Proven ability to lead and influence project teams, committees, etc.
- Excellent organizational skills, including the ability to prioritize and be flexible to changing priorities.
- Strong interpersonal skills and able to work effectively cross-functionally and in a global environment.
- Excellent people skills with the ability to coach and manage a high-performing regulatory team.
- Creative, analytical problem solver, who acts decisively, yet communicates potential consequences so that informed business decisions can be made.
- Experience facilitating FDA or EMA inspections and auditing internal operations, vendors, and contract manufacturing and contract analytical laboratories.
- Experience in project team management and leadership.
- Sufficient knowledge of all stages of pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance, and documentation.
- Business travel as required (10 -15%)
- Remote work is acceptable.