Regulatory Affairs Postdoctoral Research Fellow

About the role

The Regulatory Affairs Postdoctoral Research Fellow is a two-year experiential fellowship based in Cambridge, MA, partnering Northeastern University and Alnylam Pharmaceuticals. The fellow will gain deep exposure to global regulatory strategy across rare and prevalent disease programs.

Key responsibilities

• Support, prepare, and submit regulatory filings such as INDs, clinical trial applications, NDAs, and international marketing authorizations.
• Participate in cross‑functional meetings to contribute to clinical development plans and regulatory strategies.
• Conduct guidance and precedent research to inform regulatory approaches.
• Support lifecycle maintenance submissions for commercial programs.
• Assist in preparation of U.S. and international regulatory submissions as assigned.

Required profile

• Doctor of Pharmacy degree from an ACPE‑accredited institution.
• Eligibility for pharmacist licensure in Massachusetts.
• Excellent oral and written communication skills.
• Strong time‑management and leadership abilities.
• Ability to work independently and take initiative on projects at both the industry site and Northeastern.

Required skills

• Preparation and submission of a wide range of regulatory filings.
• Participation in cross‑functional regulatory strategy meetings.
• Guidance and precedent research to support regulatory decisions.
• Lifecycle maintenance of commercial regulatory submissions.
• Assistance in preparation of U.S. and international regulatory documents.