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Northeastern University · 4 months ago

Alnylam Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow

Boston, MA

Full-time

Onsite

New Grad, Entry Level

$59K/yr - $84K/yr

Northeastern University is offering a two-year Regulatory Affairs fellowship in partnership with Alnylam Pharmaceuticals. The role involves supporting and managing regulatory filings and collaborating with various teams to achieve regulatory milestones while gaining hands-on experience in Global Regulatory Strategy within the pharmaceutical industry.

Education

Growth Opportunities

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

Qualification

Doctor of Pharmacy degreePharmacist licensureRegulatory submissionsProject managementOral communicationWritten communicationTime managementLeadership abilitiesIndependent workInitiative