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Alnylam Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow
Northeastern University
Application
Details
Posted: 18-Oct-25
Location: Boston, Massachusetts
Type: Full-time
Internal Number: 6656744
Alnylam Pharmaceuticals-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
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their
genetic source by 'interfering' with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.
Responsibilities
Overview
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 hands-on project-based exposure across other regulatory affairs disciplines as described below:
Key Responsibilities:
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
Collaborate with Clinical, Global Patient Safety and Risk Management, Biostatistics, and Medical teams in US and EU to achieve regulatory milestones
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, 2025:
Three formal letters of recommendation (LORs) should be sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 21, 2025. LOR writers must include the candidate's name and the fellowship program(s) in the subject line (e.g., Smith, John - Alnylam, GSK).
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
Position Type
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: $59,425.00 - $83,935.00
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.
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.