Vertex – Regulatory Affairs Postdoctoral Research Fellow

## Vertex – Regulatory Affairs Postdoctoral Research Fellow Apply:
Boston, MA (Main Campus):
Full time:
Posted Today:
R142363
** About the Opportunity**## About the Opportunity 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, Vertex Pharmaceuticals Incorporated (Vertex) is offering a two-year Global Regulatory Affairs (GRA) fellowship, based in Boston, MA.## About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas.

Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type
1.Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For.

For company updates and to learn more about Vertex's history of innovation, visit  or follow us on Linked In, Facebook, Instagram, You Tube and X.## 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. Specific opportunities may vary depending on the interests of the PharmD fellow(s) as well as the needs of the department. Overall, the structured program will provide a cumulative set of skills that will help facilitate a smooth transition to a successful career after the fellowship.

Global Labeling
* Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends
* Lead team in negotiating and maintaining competitive labeling with health authorities globally

Regulatory Strategy
* 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## 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…