Vice President, Regulatory Affairs
260 Littlefield Ave. South San Francisco, CA 94080
Vice President, Regulatory Affairs
South San Francisco, CA
The VP Regulatory Affairs will be reporting to the Company' s Chief Medical Officer and will be an integral part of the company’ s leadership team. This role will work closely with the CMO and other members of the senior executive team to develop and advance regulatory strategy, establish the regulatory vision, and be an important external " face" representing the Company with regulatory agencies around the world.
Primary responsibilities will include developing a regulatory roadmap for pipeline development compounds, ensuring to maintain compliance with internal, Federal, State, International and other regulations governing Company business for all functional areas (CMC, clinical, nonclinical and commercial).
The position is based in South San Francisco and requires residence in the Bay Area.
- Oversee the Regulatory Assurance function to ensure Company’ s compliance with applicable internal standards, FDA and other regulations, and associated requirements for pharmaceutical development.
- Develop global regulatory strategy for marketing applications
- Pro-actively drive communications with all regulatory bodies to obtain all necessary IND’ s and other regulatory pre-approvals for clinical research, as well as BLA/MAA approvals for Company products on a timely basis.
- Serve as the primary liaison to US and international regulatory authorities for site inspections, presentations, submissions, and compliance matters.
- Lead the development of regulatory submissions for FDA, EMA and other international agencies.
- Guide the establishment of procedures and processes that ensure document compliance with Regulatory Company guidance/template specifications and data standards.
- Establish, develop and implement a pharmacovigilance system to ensure the quality, efficacy and safety of all products.
- Oversee Regulatory Affairs product files to support compliance with all regulatory requirements.
- Oversee the required regulatory processes for studying investigational drugs.
- BS degree in any of the physical and life sciences such as Chemistry, Biology and Microbiology required. Advanced degree and/or professional certification preferred.
- 15+ years in the pharmaceutical industry with direct regulatory experience in submissions and FDA interactions for new drugs (must include large molecules, including INDs, BLAs).
- Previous Orphan Drug experience.
- Blood product experience, hemophilia and hemostasis therapies a plus.
- Experience with a subcutaneously administered agent, a plus.
- Must have strong domestic US and European experience successfully interacting with regulatory authorities.
- Previous experience dealing with Blood Products Advisory Committee would be ideal.
- Expert knowledge of current FDA and EMA laws, rules and relevant guidance documents specifically relating to biologics.
- Demonstrated leader in Regulatory Affairs writing and submission compilation: Hands-on regulatory writing and document management will be required.
- Experience managing consultants and contractors and ensuring the integrity and timeliness of their work.
- Extensive knowledge and experience with eCTD regulatory filings/ FDA electronic submissions.
- Extensive knowledge of U.S. and International regulations including cGMP, GCP, GLP, ICH guidance documents.
- Strong understanding of Drug Development R&D, manufacturing, laboratory, and Quality Systems.
- Previous participation in package insert negotiation.
- Based in San Francisco.
- Demonstrated skills in Core Competencies:
- Drive, Intensity, Enthusiasm
- Goal Orientation/Commitment to Task/Follow-up
- Attention to Quality & Detail
- Decision Making & Problem Solving