Job Description

Overview Regulatory Affairs fellowship at Alnylam Pharmaceuticals, based in Cambridge, MA, is a two-year program offered in partnership with Northeastern University as part of the Northeastern University Pharmaceutical Industry Fellowships Program. Fellows work with biopharmaceutical industry partners and Northeastern faculty on professional development, teaching, service, and scholarly activities, with the goal of preparing Fellows to meet evolving workforce needs across the pharmaceutical industry. Alnylam Pharmaceuticals (Nasdaq: ALNY) advances RNA interference (RNAi) therapeutics to transform lives. Since our founding in 2002, we have led the RNAi Revolution and continue to translate scientific possibilities into medicines. Our culture: Our people-first culture is guided by core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people. We have been recognized as a top employer globally, including as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, and other industry recognitions. We are committed to inclusive recruitment and equal employment opportunity. We strive to create an environment where employees can belong, bring their authentic selves to work, and realize their full potential. Qualified applicants will receive consideration for employment without regard to 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 creates and implements global regulatory strategies to support expedited drug development and approval of Alnylam products, with ongoing support throughout the product lifecycle. During the two-year fellowship, the Regulatory Affairs fellow will develop a deep understanding of Global Regulatory Strategy across development programs in rare and prevalent diseases and gain hands-on project-based exposure across other regulatory affairs disciplines, as described below: 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 the 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 Application Materials & Schedule Applicants should submit the following materials by the priority deadline of October 31, 2025: Curriculum vitae (CV), uploaded Unofficial PharmD transcripts, uploaded Cover letter, uploaded 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 & Benefits 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, including medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement, and commuting & transportation. Visit 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 law. Compensation Grade/Pay Type: 108S Expected Hiring Range: $59,425.00 - $83,935.00 With the pay range shown above, the starting salary depends on education, experience, location, knowledge, and skills, and on pay comparison to similarly-situated employees. Salary ranges are reviewed regularly and are subject to change. #J-18808-Ljbffr Northeastern University

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