What are the responsibilities and job description for the Sr Manager/Associate Director, Regulatory Affairs position at Stratacuity: Proven Scientific Placement?
Contractor, Sr. Manager/Associate Director, Regulatory Affairs
Our Waltham based client is looking for an experienced Regulatory Affairs professional to lead U.S. regulatory strategy and serve as a key liaison with the FDA. In this role, you’ll guide development programs, manage complex submissions, and drive high‑quality regulatory deliverables across cross‑functional teams. This role requires 2 days per week onsite in Waltham, MA.
Responsibilities
- Lead planning and submission of regulatory dossiers (INDs, meeting packages, orphan/fast track requests, PSPs, etc.).
- Serve as Regional Regulatory Lead for assigned programs.
- Develop U.S. regulatory strategy and stay current with evolving requirements.
- Act as primary FDA contact and support teams in interpreting feedback.
- Anticipate regulatory risks and guide teams through innovative pathways, including rare disease programs.
Qualifications
- Bachelor’s in Chemistry, Pharmacy, or Biological Science (preferred).
- 4 years regulatory experience; 6 years in pharma/biotech.
- Strong understanding of U.S. regulations and drug development.
- Excellent communication and cross‑functional collaboration skills.
- Ability to manage multiple projects and provide strategic regulatory leadership.
If you’re a proactive, strategic regulatory leader ready to make an impact, we’d love to hear from you.
Salary : $100 - $125