Regulatory Affairs Fellowship: Global Strategy & Submissions

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

Job summary

Alnylam Pharmaceuticals, in partnership with Northeastern University's Pharmaceutical Industry Fellowships Program, offers a two-year Regulatory Affairs fellowship based in Cambridge, MA. Fellows gain exposure to global regulatory strategy across development programs for RNAi therapies, working with industry partners and Northeastern faculty on professional development and scholarly activities.

Responsibilities include assisting with regulatory filings, supporting regulatory strategy, and

Qualifications

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

Responsibilities

• Support, prepare, and submit a wide range of regulatory filings such as INDs, CTAs, NDAs, and international submissions.
• Participate in cross-functional meetings to support clinical development plans and regulatory strategy.
• Conduct guidance and precedent research to support regulatory strategy.
• Support development and lifecycle maintenance submissions for commercial programs.
• Assist in the preparation of U.S. and/or international regulatory submissions as assigned.

Skills

Oral communication

Written communication

Time management

Leadership

Independent work

Education

Doctor of Pharmacy (PharmD)

Job description

Alnylam Pharmaceuticals, in partnership with Northeastern University's Pharmaceutical Industry Fellowships Program, offers a two-year Regulatory Affairs fellowship based in Cambridge, MA. Fellows gain exposure to global regulatory strategy across development programs for RNAi therapies, working with industry partners and Northeastern faculty on professional development and scholarly activities.

Responsibilities include assisting with regulatory filings, supporting regulatory strategy, and