Regulatory Affairs Specialist

il y a 4 jours


Paris, Île-de-France Alnylam Pharmaceuticals Inc. Temps plein
Key Responsibilities:

As a Regulatory Affairs Specialist at Alnylam Pharmaceuticals Inc., you will provide strategic regulatory advice to internal stakeholders regarding tactics and communications related to Alnylam's marketed products, investigational treatments, and disease areas to healthcare providers, patients, payers, and other audiences. You will help build the USAP team and capabilities and may be responsible for supervising or mentoring more junior team members and fostering their professional development.

Collaboration and Communication:
Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance, and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s).

Regulatory Review and Liaison:
Act as Alnylam's liaison to the FDA's Office of Prescription Drug Promotion (OPDP) for assigned product(s), including preparing correspondence for advisory comment submissions and conducting negotiations.

Requirements:
Highly skilled in written and verbal communications, including a facility for understanding and communicating scientific, medical, and legal concepts and information.
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