Alnylam Pharmaceuticals – Regulatory Affairs Postdoctoral Research Fellow

Northeastern University•Boston, MA

23h•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 our 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. Alnylam is a leader in RNAi therapeutics, an approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Their deep pipeline, late-stage programs, and bold vision reflect their core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. They are a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another. Alnylam commits to an inclusive recruitment process and equal employment opportunity.

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
Must be able to maintain valid work authorization in the United States throughout the entire appointment without Northeastern University's sponsorship for a visa.

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