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