Sr. Director/Director of Regulatory Affairs
Piper Companies is looking for a Sr. Director/Director of Regulatory Affairs who is responsible for Regulatory activities within and outside the US including, regulatory interactions, regulatory strategy and guidance and coordinating regulatory activities for a small Biotechnology company located in Chesterbrook, PA.
Responsibilities for the Sr. Director/Director of Regulatory Affairs include:
- Develop regulatory strategy for development and commercial projects
- Regulatory guidance to support various departments
- Coordinate regulatory project operations services
- Manages & drafts in securing approval of FDA meeting requests
- Manages labeling documents
- Responsible for managing the compilation, submission and maintenance of INDs, NDAs, amendments and supplements
Qualifications for the Sr. Director/Director of Regulatory Affairs include:
- Bachelor’s Degree in Life Sciences or chemistry discipline
- 7+ years of regulatory experience in the pharmaceutical or biotechnology industry, preferably in an in-house capacity.
- Experience in working with development project teams in a regulatory leadership role.
- Experience with FDA regulations and their impact across the entire development cycle including promotion of pharmaceutical products and labeling.
- Experience across multiple therapeutic areas is a plus – CNS Preferred
Compensation for the Sr. Director/Director of Regulatory Affairs include:
- Permanent Position
- Salary: Up to $265,000 + Bonus
- Independence Blue Cross, PPO Plan
- 25 days PTO, 14 company holidays
- Company shut down between Christmas & New Years
Keywords: Regulatory Affairs, IND, NDA, FDA, CNS, Oncology, Labeling, Global Regulatory Affairs, US, EU