Associate Director, Regulatory Affairs - CMC

Insmed Inc. • Bridgewater, NJ • 6h ago

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders to formulate regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with different regions that incorporates risk identification and mitigation for the post approval change programs and potentially for development programs.What You'll Do: Accountable for reviewing and approving all CMC change control documents and disposition of proposed changes and scheduling submissions as necessary based on the changes. Keep abreast of all pertinent regulations and guidance documents for post approval submissions. Work closely with cross-functional teams to ensure short- and long-term objectives are achieved in a proactive and time efficient manner. Lead the development of post-approval submissions and development programs. Identify key CMC content requirements based on internal technical documents provided by Technical Operations or from CMOs to support development program and life cycle management, and ensure they meet current regulatory standards, are of high quality, consistent, and complete. Establish product specific strategies to ensure successful development of CMC submission packages to support product life cycle management. Work effectively with regulatory colleagues and continuously improve regulatory systems, teamwork, and efficiency.Who You Are: Bachelor's degree in a scientific subject area required; advanced degree is a plus. Minimum of 7 years experience within the biotechnology or pharmaceutical industry and development knowledge of different dosage forms in US and Ex-US is desirable. Prior experience within a GMP environment with a firm understanding of industry regulations and best practices. Solid understanding of US, EU, and Japanese regulations for human drugs/biologics. Knowledge of global regulatory guidance documents and regulations with emphasis on the requirements of post approval changes and implementation. Ability to understand and interpret complex scientific issues across multiple projects and navigate regulatory requirements in different countries/regions. Experience with Veeva Vault is nice to have. Results driven and team-oriented with the ability to influence outcomes as necessary. Excellent organizational, writing, communication, and time management skills.#LI-MM1#LI-RemotePay Range:$147,000.00-206,333.00 AnnualLife at InsmedAt Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.Highlights of our U.S. offerings include: Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration * 401(k) plan with a competitive company m

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