Regulatory Affairs Postdoctoral Research Fellow

About the role

The two‑year Regulatory Affairs Fellowship provides hands‑on experience developing and implementing regulatory strategies for a biopharmaceutical affiliate of BridgeBio. Fellows work closely with cross‑functional teams and gain exposure to regulatory submissions, labeling, and promotional material review.

Key responsibilities

• Develop and execute regulatory strategies for development programs, including IND, CTA, NDA/MAA submissions and amendments.
• Maintain and use the Veeva regulatory management system to prepare high‑quality regulatory documents.
• Support global labeling strategy, maintain core labeling documents, and respond to health‑authority queries.
• Review promotional and non‑promotional materials for compliance with FDA, ICH, PhRMA, and internal policies.
• Collaborate with Clinical, Statistics, Medical Affairs, Commercial, and Non‑clinical teams to align regulatory activities.

Required profile

• Doctor of Pharmacy (PharmD) from an ACPE‑accredited institution.
• Eligible for pharmacist licensure in Massachusetts.
• Excellent oral and written communication, strong time‑management and leadership abilities.
• Ability to work independently on projects at both the industry site and Northeastern University.

Required skills

• Proficiency with Veeva regulatory management system.
• Knowledge of ICH, GCP, GMP, and other global regulatory guidelines.
• Experience preparing regulatory submissions (IND, CTA, NDA/MAA) and labeling documents.