This clinical-stage pharmaceutical company develops innovative drugs for the treatment of schizophrenia and other CNS disorders. Their lead candidate will be entering Phase 3 this year based upon their strong Phase 2 trial results. They are seeking a Head of Regulatory Affairs (Vice President) to establish and lead the regulatory function for the company. You will develop and execute regulatory strategies for a portfolio of programs while serving as a key member of the management team. This company offers a collaborative company culture and great employee benefits including unlimited vacation time. Now is an exciting time to join this growing organization and help to get innovative medicines approved!
- Establish and lead the regulatory affairs function for the organization
- Develop appropriate regulatory strategies for projects at all stages of development, in collaboration with cross-functional team members.
- Serve as the primary point of contact for all FDA interactions, including the preparation and regulatory leadership for key meetings including pre-IND, End of Phase 2, pre-NDA, label negotiations, etc.
- Manage the preparation and timely submission of regulatory documents, including INDs, briefing documents for key meetings, NDAs, Dossiers, responses to regulatory requests and required periodic reports.
- Serve as the primary conduit on all Regulatory matters for senior leadership.
- Develop and maintain strong relationships with regulatory agency staff.
- Utilize regulatory expertise to advise teams on broader development issues to help ensure commercial success.
- Collaborate with third party regulatory consultants, and CRO’s to supplement expertise and operational capacity, with the ultimate goal of building and staffing a broader regulatory affairs function.
- Serve as the subject matter expert on regulations, guidance documents, contemporary regulatory practices and relevant regulatory precedence to guide the overall development plans accordingly.
- Proactively monitor changes in the regulatory environment and provide recommendations to R&D staff on how to address them appropriately, including modifications to development plans.
Knowledge and Skills:
- PhD, MD or Master degree in a relevant scientific area.
- 10 or more years of regulatory affairs experience in drug development for pharmaceutical drugs.
- Therapeutic area experience in CNS, Psychiatry, Neurology, and Pain highly preferred.
- Experience working with the FDA is required. Global regulatory agency experience a plus.
- Strong regulatory strategy experience across all phases of development, including Phase 3 pivotal trials and NDA filings.
- Experience in a small pharma company environment preferred.
- Excellent verbal and written skills. Attention to detail and quality are critical to success.
- Able to command respect from peers, be a team player and a role model.
- Capable of highly independent, hands-on regulatory work.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
- Proven ability to manage multiple projects, identify and resolve issues.