Director, Regulatory Affairs and Compliance
3 days ago
The Director for U.S. Advertising and Promotion will provide strategic regulatory guidance to internal stakeholders on communications related to Alnylam's marketed products, investigational treatments, and disease areas. This role will enable achievement of business objectives while ensuring compliance with U.S. laws and regulations and Alnylam policies.
Key Responsibilities- Collaborate with Commercial, Medical Affairs, Legal, and Compliance teams to create promotional and disease awareness communications, field training materials, and scientific exchange materials.
- Regulatory Reviewer on Commercial and Medical Review Boards for assigned products.
- Act as Alnylam's liaison to the FDA's Office of Prescription Drug Promotion for assigned products, including preparing correspondence for advisory comment submissions and conducting negotiations.
- Support achievement of corporate goals by using flexible and innovative approaches while mitigating risk.
- Serve as internal expert on U.S. laws and regulations, FDA guidance documents, and enforcement actions.
- Contribute to a culture of compliance at Alnylam by educating colleagues on the regulatory framework and environment, providing risk assessments, and participating in policy development.
- 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.
- BS/BA degree; advanced degree desirable but not required.
- 10 years of relevant professional experience, including at least 3 years in Regulatory Affairs in a U.S. advertising and promotion role.
- Expert in U.S. law, regulations, and FDA guidance documents related to communications about prescription drugs, investigational treatments, and disease education.
- Experience with product launches and communicating with the FDA's Office of Prescription Drug Promotion is highly desirable.
- Prior experience in supporting products for prevalent diseases is a plus.
Alnylam Pharmaceuticals has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people. We are committed to an inclusive recruitment process and equal employment opportunity, and we are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential.
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