This client is a privately-held, pre-clinical stage biopharma company in South San Francisco which is developing cell and gene therapies for heart failure. They are seeking a Regulatory Affairs Director or Sr. Director to establish the regulatory function and recommend strategies to bring their innovative programs into the clinic and advance them towards approval. This is a unique opportunity to manage all regulatory activities and contribute to major company decisions. This company offers a dynamic start-up environment, competitive salary, stock options, excellent benefits, and the potential to work from home 1-2 days a week.
- Identify and recommend strategies for successfully and efficiently achieving product approvals in G7 geographies, including exploration of expedited paths.
- Serve as the primary liaison with regulatory authorities for the specific programs.
- Plan, prepare, and review submissions to regulatory authorities including FDA (CBER), EMA (ATMP/CAT), PMDA and other major national regulatory authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA).
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities.
- Coordinate and prepare responses to questions, requests for information from regulatory authorities.
- Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements.
- Bring the Regulatory Affairs functional perspective to the table as the company makes important early decisions about nominating development candidates and building a diverse pipeline of programs and indications.
- Making the case for strategic decisions to the Management Team, Board, and other advisory groups, including related to product development, study design, acceleration opportunities, etc.
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables.
- Recruit a broader team of regulatory professionals as needed over time, and identify and retain consultants where needed.
- Act as the global regulatory lead with early, pre-clinical experience to the end of Phase II and represent the regulatory function on related cross-functional program teams.
- Work with project teams to resolve complex project issues.
- Monitor, analyze, disseminate, and recommend actions based on intelligence on regulatory matters that may affect the company and ongoing development programs.
- BS in scientific field required. MS, PhD or PharmD preferred.
- 8 to 15 years of regulatory affairs experience in the biopharma industry.
- Regulatory experience with innovative therapies (biologics, cell therapy, gene therapy or another novel modality) is highly desirable.
- Demonstrated track record of engaging thoughtfully, creatively, and collaboratively with regulatory agencies to create a path for a new modality to advance into and through the clinic.
- Experience engaging with regulatory agencies at different stages and filing relevant submissions.
- Early preclinical development consultations through IND/CTA and eventually end of Phase II is a must.
- Recent experience with BLA/NDA/MAA submissions and product lifecycle management is a plus.
- Thorough knowledge of relevant FDA and EMA regulations that are relevant to cGMP manufacturing environments.
- Global experience is highly preferred, including interactions with EMA and EU national authorities (e.g. UK, France, Germany) and/or Japanese PMDA is a plus.
- Knowledge of and experience working in the cardiovascular field in general – and the heart failure field in particular – is a plus but not required.
- Demonstrated ability to plan and execute; excellent analytical skills and an ability to communicate complex issues to a broad audience (oral and written).
- High bandwidth for implementing technical, strategic, and operational plans with a proven track record in identifying and resolving critical issues.
- Outstanding communication skills, with the ability to articulate a strategy and build support internally and externally.
- Must thrive working in a fast-paced, innovative environment requiring flexibility, strategic agility, and creativity.