Senior Director, Regulatory Affairs CMC Policy and Advocacy

Overview

The Senior Director, Regulatory Affairs CMC Policy and Advocacy will lead the development and implementation of global regulatory advocacy strategies.  This role will also oversee global regulatory CMC policy review process to ensure thorough analysis and understanding of evolving regulatory policies and to provide advice and implementation strategies for impacted Alnylam’s portfolio. This position will require an individual who is well placed and connected within the pharmaceutical industry as well as an individual who has a passion for driving policy and advocacy initiatives.

Summary of Key Responsibilities

• Collaborate with global regulatory agencies and legislative bodies to help develop scientifically sound regulatory policy for Alnylam’s innovative technologies and manufacturing platforms.
• Develop and implement global advocacy strategies to influence the global regulatory environment related to product manufacturing, in alignment with the company technology platform and goals
• Synthesize complex regulatory information into clear recommendations, keeping colleagues well-informed about relevant policy developments
• Lead the international policy review process at Alnylam for all CMC-related topics, ensuring comprehensive analysis of evolving regulatory policies and providing clear guidance and strategic recommendations to internal stakeholders.
• Collaborate with cross-functional teams (e.g. PPGR, TOQ) and stakeholders to derive aligned company positions on policy matters.
• Represent the company in external forums and trade associations, advocating for the company interests and building strategic relationships.
• Leverages technical expertise, regulatory intelligence, and global regulatory insights to shape best practices and drive consistency in dossier preparation processes across regions.
• Monitor and communicate changes in the global regulatory landscape and shifting regulations through internal regulatory intelligence channels to ensure timely implementation.
• Actively participate in RA CMC infra-structure 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 science industry, with direct hands-on experience in relevant fields, such as 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 relevant to global product development, registration and post-market support
• Knowledge and understanding of US, EU, Canada, and ICH guidelines pertinent to CMC and post-approval landscape. Understanding of international requirements is a plus.
• Strong communication skills with demonstrated track-record to effectively communicate complex and technical information
• Strong interpersonal skills; ability to influence key stakeholders
• Excellent written and communication skills and attention to detail.

U.S. Pay Range

$234,100.00 - $316,700.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another. 

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.