Associate Director, Regulatory Affairs (CMC)
About The Position
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: We’re looking for an Associate Director, Regulatory Affairs CMC on the Regulatory Affairs CMC team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Regulatory Affairs CMC, EMEA, you’ll have responsibility for leading CMC regulatory strategy development and implementation that incorporates risk identification and mitigation for assigned development and post approval programs to achieve regulatory approvals in the EMEA region.
Requirements
- A minimum of a Bachelor's degree
- 5-7 years of pharmaceutical development and regulatory CMC experience in the biotechnology or pharmaceutical industry.
- Prior experience within a GMP environment with a firm understanding of industry regulations and best practices.
- A solid understanding of EU/ICH regulations and other country specific guidelines for small molecules and/or biologics.
- Knowledge of global regulatory guidance documents and regulations with emphasis on the interrelationship between CMC and all other development. functions (for example, clinical supplies, qualification of impurities via toxicology testing, etc) as related to the overall global regulatory strategy.
- Understanding and interpretation of complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
Nice To Haves
- Biologics and inhalation drug product development knowledge in EMEA region is desirable.
Responsibilities
- Plan and coordinate regulatory submissions to support projects in development and commercial applications, including lifecycle management of products in the EMEA region.
- 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 CMC background documentation for consultation with the EMA, MHRA and other regulatory authorities.
- Identify key CMC content requirements and author the CMC sections for IND/IMPD, NDA/MAA, and other regulatory submissions based upon internal technical documents provided by Tech Operations or from vendor supplied documents to support clinical studies and product registrations, ensuring they meet current regulatory standards and are of high quality, consistent, and complete.
- Establish product specific strategies to ensure successful development of CMC submission packages to support early development, registration and life cycle management.
- Have accountability for reviewing and approving all CMC change control documents and disposition of proposed changes relating to products in the EMEA region, scheduling submissions as necessary based on such changes.
- Provide interpretation of applicable EMA/ICH/WHO, and other country specific regulations to ensure the compliance of CMC content within regulatory filings.
- Keep abreast of all pertinent regulations and guidance documents for pre and post approval submissions.
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support
- Annual wellbeing reimbursement
- Access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- Annual equity awards
- Participation in our Employee Stock Purchase Plan (ESPP)
- Company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups
- Service and recognition programs
- Meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
