Associate Director, Regulatory Affairs (CMC)
Insmed Incorporated
August 19, 2026
Remote
United States
Corporate Functions
Associate Director, Regulatory Affairs CMC (Regulatory Affairs CMC team)
Responsibilities:
- Lead CMC regulatory strategy development and implementation for assigned development and post-approval programs to achieve EMEA regulatory approvals, including risk identification and mitigation.
- Plan and coordinate regulatory submissions for development and commercial applications, including lifecycle management in EMEA.
- Collaborate with cross-functional teams to achieve short- and long-term objectives proactively and efficiently.
- Develop CMC background documentation for consultation with EMA, MHRA, and other authorities.
- Author CMC sections for IND/IMPD, NDA/MAA, and other submissions using internal technical documents and vendor documents; ensure quality, consistency, completeness, and current regulatory compliance.
- Establish product-specific strategies for successful CMC submission packages (early development, registration, lifecycle management).
- Review/approve CMC change control documents and manage disposition/scheduling of submissions as changes occur.
- Interpret applicable EMA/ICH/WHO and country-specific regulations; stay current on guidance for pre- and post-approval submissions.
Qualifications/Requirements:
- Bachelor’s degree.
- 5–7 years of pharmaceutical development and regulatory CMC experience (biotech/pharma).
- GMP experience; strong understanding of EU/ICH and country-specific guidance for small molecules and/or biologics.
- Knowledge of global regulatory guidance and the CMC–development function interrelationship.
- Ability to interpret complex scientific issues across multiple projects.
Desirable:
- Biologics and inhalation drug product development knowledge in EMEA.
Work/Travel:
- Fully remote; occasional travel for meetings/events; minimal travel expected.
Pay Range:
- $164,000.00–213,000.00 annual.
Application:
- Current Insmed employees: apply via Jobs Hub in Workday.
Responsibilities:
- Lead CMC regulatory strategy development and implementation for assigned development and post-approval programs to achieve EMEA regulatory approvals, including risk identification and mitigation.
- Plan and coordinate regulatory submissions for development and commercial applications, including lifecycle management in EMEA.
- Collaborate with cross-functional teams to achieve short- and long-term objectives proactively and efficiently.
- Develop CMC background documentation for consultation with EMA, MHRA, and other authorities.
- Author CMC sections for IND/IMPD, NDA/MAA, and other submissions using internal technical documents and vendor documents; ensure quality, consistency, completeness, and current regulatory compliance.
- Establish product-specific strategies for successful CMC submission packages (early development, registration, lifecycle management).
- Review/approve CMC change control documents and manage disposition/scheduling of submissions as changes occur.
- Interpret applicable EMA/ICH/WHO and country-specific regulations; stay current on guidance for pre- and post-approval submissions.
Qualifications/Requirements:
- Bachelor’s degree.
- 5–7 years of pharmaceutical development and regulatory CMC experience (biotech/pharma).
- GMP experience; strong understanding of EU/ICH and country-specific guidance for small molecules and/or biologics.
- Knowledge of global regulatory guidance and the CMC–development function interrelationship.
- Ability to interpret complex scientific issues across multiple projects.
Desirable:
- Biologics and inhalation drug product development knowledge in EMEA.
Work/Travel:
- Fully remote; occasional travel for meetings/events; minimal travel expected.
Pay Range:
- $164,000.00–213,000.00 annual.
Application:
- Current Insmed employees: apply via Jobs Hub in Workday.