Senior Director, Regulatory Affairs - Part Time Contract
Regulatory | San Carlos, CA | Part Time and Temporary
The Senior Director will serve as the Global Regulatory Leader (GRL) for defining and implementing the Regulatory strategy for assigned programs. This individual will also manage regulatory labeling through all phases of development and post-approval.
ChemoCentryx Regulatory leaders are self-driven, motivated, strategic and execution-oriented optimizing regulatory pathways.
Essential Duties & Responsibilities:
- Provide regulatory strategic and tactical leadership for drug development projects, including health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives, timelines and budgets
- Label creation, content generation experience highly valued
- Serve as liaison with FDA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements
- Ensure completeness and accuracy of information provided in regulatory submissions.
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs
- Must have excellent writing skills
- BS Required. Advanced degree is preferred (MS/PhD/PharmD)
- 10+ years regulatory affairs in bio/pharma industry
- The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment
- Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities
- Experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, PSURs, IMPD’s, and Briefing packages and other regulatory submissions required
- Experience interacting/negotiating with regulatory authorities (e.g. FDA, EMA, etc.)
- Strong leadership and communication skills and experience in working with multiple functional areas
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
- Excellent oral communication and writing skills
- Delivery of a number of major applications (NDA/BLA/MAA/JNDA etc.) and lead role preferred.
- Prior experience in the immunology therapeutic area would be helpful