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Director, Regulatory Affairs U.S. Advertising And Promotion (USAP)
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Full-time
- 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 Reviewer on Commercial and Medical Review Boards for assigned product(s)
- Monitor new or revised legislation, regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, scientific exchange, and human subject protection, and analyze and communicate their relevance to Alnylam
- Work closely with Regulatory Operations in making timely submissions of promotional materials to FDA
- 10 years of relevant professional experience, including at least 3 years in Regulatory Affairs in a U.S. advertising and promotion role
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