Regulatory Affairs Postdoctoral Research Fellow

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 www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube 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 time management and leadership abilities
• Ability to work independently and take initiative on a variety of projects at both the industry site and Northeastern

Additional Information

Applicants should submit the following application materials by the priority deadline of October 31, 2026.

1. Curriculum vitae (CV), uploaded
2. Unofficial PharmD transcripts, uploaded
3. Cover letter, uploaded

Letters of Recommendation

Three formal Letters of Recommendation (LORs) must be submitted directly by the letter writers no later than November 23, 2026.

Each letter writer must include:

·       The candidate's full name

·       The fellowship program(s) to which the candidate is applying (e.g., Smith, John – Alnylam, GSK)

Please ask your letter writers to complete and submit the Letter of Recommendation Form along with their recommendation. Click here to access the form and share it with your letter writers.

Recommendations must be submitted directly by the recommender and cannot be submitted by the applicant.

Address cover letter and letters of recommendation to:

J. Andrew Orr-Skirvin, PharmD, BCOP
Clinical Professor, Department of Pharmacy & Health Systems Sciences

Pharmaceutical Industry Fellowship Program Director

360 Huntington Ave, 140 The Fenway R218
Boston, MA 02115

Northeastern University will not provide H-1B, TN, O-1, E-3, or any other type of employment visa sponsorship for the successful applicant to this position, now or in the future.  STEM OPT is not compatible for this position. The successful applicant must be able to maintain valid work authorization in the United States throughout the entire appointment without Northeastern University's sponsorship for a visa. 

Position Type

Research

Additional Information

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.  

All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

Compensation Grade/Pay Type:

108S

Expected Hiring Range:

$60,315.00 - $85,192.50

With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role. Salary ranges are reviewed regularly and are subject to change.