BridgeBio-- Regulatory Affairs Postdoctoral Research Fellow

Develop proficiency within the Veeva regulatory management system where you will support the planning, preparation and execution of high-quality regulatory submissions (e.g. Clinical Trial Application (CTA)/Investigational New Drug (IND) application and amendments, annual reports, initial license applications (New Drug Application (NDA)/Marketing Authorization Application (MAA), etc.) and supplements/variations).

Develop and maintain knowledge of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other relevant global guidelines to ensure compliance of regulatory strategies and submissions.

Work in cross-functional teams with members from Clinical, Statistics, Medical Affairs, Commercial, and Nonclinical groups to help operationalize regulatory strategy.

Support regulatory interactions with regulatory bodies including preparation of meeting requests and briefing documents.

Global Labeling

• Gain in-depth knowledge of labeling regulations regarding Company Core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), and Structured Product Labeling (SPL).
• Support development of regulatory labeling strategy and the negotiation and maintenance of competitive labeling with global health authorities.
• Maintain core labeling documents.
• Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends and work with cross-functional team to ensure that the regulatory labeling strategy is aligned with the global regulatory strategy.
• Assist in preparation of responses to labeling-related queries from health authorities.
  

Advertising and Promotion (Medical, Legal, and Regulatory (MLR))

• Support regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, health authority regulations, ICH guidelines, Pharmaceutical Research & Manufacturers of Americans (PhRMA) guidelines, company policies and established precedents and recommend revisions/actions that achieve fair balance.
• Support the review and approval of promotional and non-promotional materials in a cross-functional promotional review committee that includes Commercial, Medical Affairs, and Legal.
• Coordinate timely and accurate review of materials for submission to the United States Food and Drug Administration (FDA).
  

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.

Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.

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:

$66,345.00 - $93,712.50

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.



To apply, visit https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/San-Jose-CA/BridgeBio---Regulatory-Affairs-Postdoctoral-Research-Fellow_R142328



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