Strategic Regulatory Advisor

il y a 4 semaines


Paris, Île-de-France Alnylam Pharmaceuticals Inc. Temps plein
As a Strategic Regulatory Advisor at Alnylam Pharmaceuticals Inc., you will play a critical role in shaping the company's regulatory strategy and ensuring compliance with relevant regulations. Your expertise will be invaluable in providing strategic advice to internal stakeholders on tactics and communications related to Alnylam's marketed products, investigational treatments, and disease areas. You will work closely with the USAP team to build capabilities and may supervise or mentor junior team members, fostering their professional development.

Key responsibilities include collaborating with colleagues in Commercial, Medical Affairs, Legal, Compliance, and other expertise areas to create promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange. You will also act as Alnylam's liaison to the FDA's Office of Prescription Drug Promotion (OPDP) for assigned product(s), preparing correspondence for advisory comment submissions and conducting negotiations. With a strong background in written and verbal communications, you will be able to effectively communicate scientific, medical, and legal concepts and information.
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