Senior Director, Regulatory Affairs CMC Policy and Advocacy

Role Summary

Senior Director, Regulatory Affairs CMC Policy and Advocacy — leads development and implementation of global regulatory advocacy strategies and oversees global regulatory CMC policy review to provide analysis and advice for Alnylam’s portfolio. Requires strong industry connections and passion for policy and advocacy initiatives.

Responsibilities

• Collaborate with global regulatory agencies and legislative bodies to develop scientifically sound regulatory policy for Alnylam‚Äôs technologies and manufacturing platforms.
• Develop and implement global advocacy strategies to influence the global regulatory environment related to product manufacturing, aligned with company goals.
• Synthesize complex regulatory information into clear recommendations and keep colleagues informed about policy developments.
• Lead the international policy review process for all CMC-related topics, ensuring thorough analysis and providing guidance to internal stakeholders.
• Collaborate with cross-functional teams to derive aligned company positions on policy matters.
• Represent the company in external forums and trade associations, advocating for company interests and building strategic relationships.
• Leverage technical expertise and regulatory intelligence to drive best practices and consistency in dossier preparation across regions.
• Monitor and communicate changes in the global regulatory landscape to ensure timely implementation.
• Participate in RA CMC infrastructure and capability-building activities.

Qualifications

• BSc in science-related field required; Advanced degree (e.g., MS, PhD) preferred.
• 10+ years of experience in the pharmaceutical/biotechnology/life sciences industry with hands-on experience in relevant fields (Product Quality, Quality Systems, Combination Products, CMC Technical Writing or Regulatory Affairs, CMC).
• Experience representing companies in trade associations and industry forums, influencing policy outcomes.
• Solid understanding of scientific principles and regulatory requirements for global product development, registration, and post-market support.
• Knowledge of US, EU, Canada, and ICH guidelines relevant to CMC and post-approval landscape; international requirements a plus.
• Strong communication skills with a track record of conveying complex technical information; strong interpersonal skills and ability to influence stakeholders; excellent written communication and attention to detail.