Regulatory Fellow—Strategy & APL (PharmD)

Northeastern University; Boston (MA); On-site; USD 60,000 - 85,000; Full time

Job summary

Intellia Therapeutics in Cambridge, MA is offering a two-year Regulatory Affairs fellowship in partnership with Northeastern University for PharmD graduates. The program blends regulatory strategy and advertising/promotion/labeling in the first year, with a second-year specialization choice.

The Fellow will join Global Regulatory Affairs, gain hands-on experience, and contribute to regulatory submissions, agency interactions, and cross-functional projects across both Intellia and Northeastern

Qualifications

• PharmD degree from ACPE-accredited institution.
• Eligible for pharmacist licensure in Massachusetts.
• Electives related to Regulatory Affairs a plus.
• Excellent oral and written communication skills.
• Interest in gene editing and CRISPR.

Responsibilities

• Develop regulatory strategies for global submissions across drug development stages.
• Collaborate on medical communications, marketing materials, and regulatory filings.
• Assist in planning regulatory submissions for trials and registrations.
• Prepare for regulatory agency meetings and briefing books.
• Coordinate with internal teams and vendors for inspections and audits.
• Lead development of methods to monitor regulatory changes and trends.

Skills

Excellent communication

Time management

Leadership abilities

Independent work

Onsite collaboration

Education

PharmD degree

Job description

Intellia Therapeutics in Cambridge, MA is offering a two-year Regulatory Affairs fellowship in partnership with Northeastern University for PharmD graduates. The program blends regulatory strategy and advertising/promotion/labeling in the first year, with a second-year specialization choice.

The Fellow will join Global Regulatory Affairs, gain hands-on experience, and contribute to regulatory submissions, agency interactions, and cross-functional projects across both Intellia and Northeastern