Alnylam Pharmaceuticals – Regulatory Affairs Postdoctoral Research Fellow

## Alnylam Pharmaceuticals – Regulatory Affairs Postdoctoral Research Fellow Apply:
Boston, MA (Main Campus):
Full time:
Posted Today:
R142336
** 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 We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible.

Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law.##

Responsibilities 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 project-based exposure across other regulatory affairs disciplines, if interested:
** Key

Job Duties:

*** 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
* 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…