Alnylam Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow

Northeastern University • Newton, MA

132d • $59,425 - $83,935

About The Position

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.

Requirements

• 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

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

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• Paid time off
• Tuition assistance
• Wellness & life benefits
• Retirement benefits
• Commuting & transportation benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Ph.D. or professional degree