Director, Regulatory Strategy
San Diego, CA
- Lead the Global Regulatory Team; develop and maintain the Global Regulatory Strategy.
- Provide critical review of all documentation supporting regulatory applications.
- Review protocols, reports, and documents used in regulatory submissions.
- Collaborate with CROs or other partnering organizations.
- Participate as a full member of the research and development team(s).
- Work with peers to develop standard operating procedures and departmental guidelines.
- Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
- Write paper and electronic submissions, as applicable, to support development project plans and timelines for IND, NDA, and MAA and related submissions, as well as amendments and supplements to these applications and responses to regulatory agency requests.
- Collaborate with responsible departments and lead preparation, review, and collection of documentation for regulatory submissions.
- Experience managing global CTA submissions.
- 5 years of regulatory experience as global regulatory leader.
- Minimum of 10 pharmaceutical industry experience.
- Excellent organization and multi-tasking skills.
- Exceptional interpersonal skills and problem solving capabilities.
- Proven negotiation skills.
- Ability to work effectively across a matrix organization.
- Demonstrated evidence of writing regulatory documents including briefing packages.
- Bachelor’s degree in Biology or Chemistry, advanced degree preferred.