Executive Director - Regulatory Affairs - Pharmaceuticals
Can live anywhere in the North East
is a groundbreaking startup with game-changing technology that will help inform value-based treatments. The first product is geared towards schizophrenia and its side effects of having this disease and the second will help treat prostate and pancreatic cancers.
Job Overview for the Executive Director - Regulatory Affairs - Pharmaceuticals
The Executive Director, Regulatory Affairs will be responsible for developing and executing the global regulatory strategy for one or more projects. This individual will, with a high sense of urgency, provide strategic and operational regulatory input to cross-functional teams responsible for global development programs. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
Responsibilities and Duties - Executive Director - Regulatory Affairs - Pharmaceuticals
- At least 15 years in pharmaceutical industry regulatory affairs, including experience in leading regulatory teams and participating in cross-functional development teams.
- Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
- Experience in all phases of development across multiple therapeutic areas including IND, NDA, and CTA experience.
- Master’s, Pharm D, or PhD Degree in a related discipline