Alnylam Pharmaceuticals – Regulatory Affairs Postdoctoral Research Fellow

Northeastern University•Boston, MA

1d•$60,315 - $85,193•Onsite

About The Position

The Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. A key element of the program’s success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities. In partnership with Northeastern University, Alnylam Pharmaceuticals is offering a two-year Regulatory Affairs fellowship, based in Cambridge, MA.

Requirements

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 investigational new drug applications, clinical trial applications, new drug applications and international marketing authorization applications
Participate in cross-functional meetings to support and contribute to the clinical development plan and regulatory strategy
Conduct guidance and precedent research to support regulatory strategy
Support the development and lifecycle maintenance submissions for commercial programs
Assist in the preparation of U.S. and/or international regulatory submissions as assigned