Job Description

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.

Job Tags

Similar Jobs