Northeastern University · 4 months ago
Vertex Pharmaceuticals-Global Regulatory Affairs Postdoctoral Research Fellow
Northeastern University is offering a two-year Global Regulatory Affairs fellowship in partnership with Vertex Pharmaceuticals, designed for Pharm.D. graduates. The role provides specialized training in Regulatory Strategy and Global Labeling, equipping fellows with essential skills for a successful career in the pharmaceutical industry.
Education
Responsibilities
The PharmD fellow(s) will have an opportunity to gain specialized and in-depth training in two distinct areas of GRA, Regulatory Strategy and Global Labeling, for a period of 8 months each
The remaining 8 months of the program will be spent in a regulatory elective
Regulatory elective opportunities are offered in areas including CMC, Advertising and Promotion, International, Policy, and Strategic Operations
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
Qualification
Required
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
Benefits
Medical
Vision
Dental
Paid time off
Tuition assistance
Wellness & life
Retirement- as well as commuting & transportation
Company
Northeastern University
Founded in 1898, Northeastern is a global research university with a distinctive, experience-driven approach to education and discovery.
Funding
Current Stage
Late StageRecent News
2024-01-06
Alfred P. Sloan Foundation
2023-10-30
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