This Bay Area biopharmaceutical company is developing medicines for patients who suffer from serious genetic diseases and cancers. They are seeking a Regulatory Affairs Senior Director who can develop and execute global regulatory strategies for the company’s rare disease and oncology programs. You will work directly with FDA and other health authorities, while helping to get transformative drugs approved. This company offers a patient-first culture, flexible PTO, and the ability to work remotely (with some regular visits to their office.) With one approved product and a program currently in Phase 2 trials, now an exciting time to join this growing organization!
- Develop and execute global regulatory strategies for product development, approval, and registration for oncology programs.
- Prepare and implement critical global regulatory submissions (from pre-IND to post-marketing) to the FDA, EMA, and other international health authorities
- Lead regulatory submission deliverables including INDs, CTAs, Orphan Drug Applications, NDAs and MAAs.
- Develop and present regulatory strategies, recommendations, and risks during senior management discussions.
- Serve as the liaison between the company and regulatory agencies (FDA, EMA, etc.) for assigned projects.
- Coordinate and prepare responses in response to Regulatory Agency requests.
- Lead and support global health authority interactions, including defining strategy, preparation, and meeting facilitation.
- Prepare regulatory development plans and manage regulatory timelines for assigned projects.
- Develop and maintain regulatory knowledge of US, EU and ROW regulations.
- Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global regulations and guidance, and provide regulatory advice to project teams.
- Bachelor’s degree in a scientific field is required. Advanced degree such as PharmD, MD, or PhD preferred
- A minimum of 10 years of Regulatory Affairs experience in the pharmaceutical industry
- Experience with oncology programs is required. Rare disease experience a plus.
- Must have track record of filing successful INDs, CTAs, NDAs or BLAs.
- Must have strong experience working directly with FDA and other health authorities.
- Be well-versed in the drug development process and regulatory requirements, and have a good understanding of the underlying science.
- Global/Ex-US Regulatory filing experience (EMA, Asia Pacific, etc) required.
- Excellent written and verbal communication skills.
- Excellent project management skills, with the ability to manage multiple projects and prioritize appropriately.
- Ability to rapidly understand & analyze complex problems/situations.
- Strong interpersonal skills and the ability to effectively work with others.
- Ability to influence without authority, lead change, and manage resistance to change.
- Ability to solicit information, persuade others, and shape outcomes.
- Experience working with all levels of management and consulting with key business stakeholders (internal and external)
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.