Vertex – Regulatory Affairs Postdoctoral Research Fellow

Northeastern University•Boston, MA

1d•$60,315 - $85,193•Onsite

About The Position

The Vertex – Regulatory Affairs Postdoctoral Research Fellow position is a two-year experiential program offered in partnership with Northeastern University's Pharmaceutical Industry Fellowships Program. This program is designed to advance lifelong learning and the education and training of Pharm.D. graduates, preparing them for evolving workforce needs in the biopharmaceutical industry. Fellows will work closely with Vertex Pharmaceuticals Incorporated (Vertex) and Northeastern University faculty on professional and career development, teaching, service, and scholarly activities. The fellowship focuses on Global Regulatory Affairs (GRA), with specific training in Regulatory Strategy and Global Labeling, and offers opportunities for regulatory electives in areas such as CMC, Advertising and Promotion, International, Policy, and Strategic Operations. The program aims to provide a cumulative set of skills to facilitate a smooth transition to a successful career post-fellowship.

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

Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends.
Lead team in negotiating and maintaining competitive labeling with health authorities globally.
Manage, develop, and implement regulatory strategy in support of Vertex products and development programs.
Provide strategic input and tactical support to expedite the development, submission, and regulatory approval of new drug or biologic products.