Regulatory Affairs Director

12 ore fa

Italia Alnylam Pharmaceuticals Inc. A tempo pieno

Director, Regulatory Affairs U.S. Advertising and Promotion (USAP)

About the Role

We are seeking a highly skilled Director, Regulatory Affairs U.S. Advertising and Promotion (USAP) to provide strategic regulatory advice to internal stakeholders regarding tactics and communications related to Alnylam's marketed products, investigational treatments, and disease areas.

Key Responsibilities

  • 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)
  • 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
  • Support achievement of corporate goals by using flexible and innovative approaches while appropriately mitigating risk
  • Serve as internal expert on U.S. laws and regulations, FDA guidance documents, and enforcement actions
  • Contribute to culture of compliance at Alnylam by educating colleagues on the regulatory framework and environment, providing assessment of risk for proposed communication tactics and strategies, and participating in development of policies and procedures
  • 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
  • Provide advice regarding clinical study design elements and labeling needed to support target product profiles and desired commercial claims
  • Help build USAP team and capabilities, including development of processes and best practices

Requirements

  • 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 a product launch or launches and in communicating with OPDP or APLB, including submissions for advisory comment, highly desirable
  • Prior experience in supporting products for prevalent diseases a plus
  • Demonstrated understanding of the importance of clinical study design and statistical principles and analyses to assessment of permissible claims
  • Highly skilled in written and verbal communications, including a facility for understanding and communicating scientific, medical, and legal concepts and information
  • Experienced in managing individuals and/or teams preferred

About Alnylam

Alnylam Pharmaceuticals (Nasdaq: ALNY) 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.

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