Postdoctoral Fellow Alnylam Regulatory Affairs

Sep 19, 2017
Position Type
Institution Type
Four-Year Institution

Northeastern University

Postdoctoral Fellow Alnylam Regulatory Affairs

Requisition Number: STFR004031

Division/College: Bouve College of Health Sciences

Location: Boston Main Campus

Full-time/Part-time: Full Time


This two-year Fellowship Program in collaboration at Northeastern University and Alnylam Pharmaceuticals is designed to offer Doctor of Pharmacy graduates an in-depth experience in a biopharmaceutical industry setting.

Alnylam focus: The Regulatory Affairs Department at Alnylam is a diverse group with scientific, technical, and clinical expertise that works collaboratively to manage all regulatory aspects of Alnylam products, including the generation and filing of investigational new drug applications, clinical trial applications, and marketing applications around the world. Regulatory Affairs provides strategic non-clinical and clinical regulatory insights to the development teams in all phases of drug development. Unique experiences in the rare disease space include orphan drug applications, breakthrough therapy and PRIME designation requests, and other novel regulatory pathways and approaches.

Longitudinal Activities

  • Regulatory intelligence, surveillance, analysis, and reporting
  • Regulatory submission and filing support
  • Regulatory annual report generation, management, and submission
  • Internal regulatory correspondence support, analysis, and trending
  • Work cross-functionally with Commercial, Medical Affairs, Clinical Development, Clinical Operations, and Information Technology to ensure the successful NDA filings of multiple RNAi therapeutics

    Core Regulatory Affairs Rotations:

  • Regulatory Strategy
  • Advertising, Labeling, and Promotional Materials
  • Chemistry Manufacturing and Controls (CMC)
  • Regulatory Technology and Operations

    Northeastern University School of Pharmacy focus: Fellows have the opportunity to teach courses in both large and small group settings and co—precept introductory and advanced practice experiential education students. Fellows will also participate in teaching seminars with residents and fellows throughout Massachusetts, and will work with Northeastern faculty in the areas of teaching and scholarly projects leading to publication and scientific presentation. The fellows will work at Alnylam's office in Cambridge, Northeastern offices on campus, as well as various clinical practice settings (hospitals, clinics, pharmacies) with Northeastern faculty.


    Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts, excellent communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at Alnylam and Northeastern.

    Additional Information:
    Applicants MUST submit ALL of the following APPLICATION MATERIALS by December 1, 2017:

    The Northeastern online application form MUST include the following items:

    1. CV and Cover Letter, uploaded

    2. Transcripts (*may be unofficial or official), uploaded

    3. Names and contact information (only) of the three persons (references) who will be submitting letters of recommendation

    PROCESS FOR REFERENCES: These 3 individuals providing recommendation letters MUST personally email their letter of reference to directly, including the candidate’s name in the subject line of the email. The deadline for receiving these is also December 1, 2017.

    The Bouvé College of Health Sciences at Northeastern University is one of nine colleges/schools at Northeastern University, and is a national model for education and research in the health, psychosocial and biomedical sciences. Comprised of three schools - Nursing, Pharmacy and Health Professions — over 2200 undergraduates and 1700 graduate students are enrolled in more than 30 degree-granting programs. Complementing our instructional programs, we house nine centers and institutes and the College successfully competes for NIH, NSF and foundation funding.

    Northeastern University is on an exciting trajectory of growth and innovation. The University is a leader in inter-disciplinary research, urban engagement, experiential learning, and the integration of classroom learning with real-world experience. Northeastern University is home to 20,000 students and to the nation’s premier cooperative education program. The past decade has witnessed a dramatic increase in Northeastern’s international reputation for research and innovative educational programs. A heightened focus on interdisciplinary research and scholarship is driving a faculty hiring initiative at Northeastern, advancing its position amongst the nation’s top research universities. Northeastern University is situated on the Avenue of the Arts in Boston’s historic Back Bay, four blocks from the Longwood Medical Area, encompassing Harvard Medical School, Boston Children’s Hospital, Brigham & Women’s Hospital, and Beth Israel Deaconess Medical Center, and eight blocks from the Boston Medical Center.

    To be considered for this position please visit our web site and apply on line at the following link: Careers@Northeastern

    Northeastern University is an Equal Opportunity, Affirmative Action Educational Institution and Employer, Title IX University. Northeastern University particularly welcomes applications from minorities, women and persons with disabilities. Northeastern University is an E-Verify Employer.


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