Global Regulatory Affairs Postdoctoral Research Fellow

About the role

The two‑year Global Regulatory Affairs Postdoctoral Research Fellowship is offered in partnership with Northeastern University and Intellia Therapeutics. Fellows will work onsite in Cambridge, MA, gaining hands‑on experience in regulatory strategy and advertising/promotion/labeling for CRISPR‑based therapeutics.

Key responsibilities

• Develop in‑depth knowledge of Intellia’s CRISPR technology and therapeutic areas to support strategic conversations and APL reviews.
• Contribute to regulatory strategy development for projects across all product development phases to achieve marketing authorization and appropriate labeling.
• Collaborate with cross‑functional teams on medical communications, marketing materials, and regulatory filings.
• Assist in planning and coordinating regulatory submissions for clinical trials, product registrations, and post‑marketing requirements.
• Prepare for agency meetings, including briefing books and high‑quality submission documents.

Required profile

• Doctor of Pharmacy (PharmD) degree from an ACPE‑accredited institution.
• Eligible for pharmacist licensure in Massachusetts.
• Strong scientific acumen and interest in gene editing/CRISPR.
• Excellent oral and written communication skills.
• Ability to work independently, manage time, and lead projects.

Required skills

• Regulatory strategy development.
• Advertising, promotion, and labeling (APL) expertise.
• Regulatory submission preparation (IND, BLA).
• Scientific data analysis related to gene editing.