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Overview

The Director, Regulatory Affairs for U.S. Advertising and Promotion (USAP) will provide strategic regulatory advice to internal stakeholders, primarily regarding direct-to-consumer (DTC) tactics related to Alnylam’s marketed products, investigational treatments, and disease areas. The ideal candidate will have prior experience supporting products within a competitive treatment landscape and providing strategic guidance for product broadcast advertisements, digital and social media tactics, media activities, and product spokespersons.

A critical aspect of this role is to enable achievement of business objectives while ensuring compliance with applicable U.S. laws and regulations and Alnylam policies. The Director, Regulatory Affairs for USAP may be responsible for mentoring more junior team members and fostering their professional development. The Director, Regulatory Affairs for USAP will report to the Senior Director of USAP.

*This a hybrid role based in our Cambridge, MA or Philadelphia, PA office.

Key Responsibilities
- Collaborate with colleagues in Commercial,



Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness communications, and field training materials for assigned product(s)
- Provide balanced risk perspectives and top-quality regulatory advice in a highly regulated market to internal stakeholders that reflects knowledge of historic and evolving enforcement trends
- Serve as Regulatory Reviewer on Commercial and Medical Review Boards for assigned product(s)
- 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, if applicable
- Support achievement of corporate goals by using flexible and innovative approaches while appropriately mitigating risk
- Serve as internal expert on applicable U.S. laws and regulations, FDA guidance documents, and

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