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, Alnylam Pharmaceuticals is offering a two-year Regulatory Affairs fellowship, based in Cambridge, MA.

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law.

Responsibilities

Regulatory Affairs at Alnylam is a global group with diverse scientific, technical, and clinical expertise. The team is responsible for creating and implementing global innovative strategies to support expedited drug development and approval of Alnylam’s products. Effective support and management continue throughout Alnylam’s product life cycle. Assuming increasing responsibility over the two years, the experience gained throughout this fellowship will allow the Regulatory Affairs fellow to develop a deep understanding of Global Regulatory Strategy across development programs within rare and prevalent diseases and gain project-based exposure across other regulatory affairs disciplines, if interested:
 

Key Job Duties:

• Support, prepare, and submit a wide range of regulatory filings such as investigational new drug applications, clinical trial applications, new drug applications and international marketing authorization applications
• Participate in cross-functional meetings to support and contribute to the clinical development plan and regulatory strategy
• Conduct guidance and precedent research to support regulatory strategy
• Support the development and lifecycle maintenance submissions for commercial programs
• Assist in the preparation of U.S. and/or international regulatory submissions as assigned

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.