Associate Director, Regulatory Affairs
Insmed Incorporated
August 11, 2026
Remote
United States
Corporate Functions
Associate Director, Regulatory Affairs
Responsibilities:
- Lead planning, execution, and oversight of global regulatory activities supporting clinical trial applications and maintenance across the product development lifecycle.
- Serve as primary regulatory lead for global clinical trial submissions; ensure timely regulatory approvals for assigned regions (US, Canada, LATAM, APAC, and others).
- Provide regulatory leadership during agency interactions; manage regulatory questions and information requests.
- Coordinate cross-functional responses to enable timely initiation and conduct of global clinical trials.
- Develop and execute global regulatory strategies for CTAs, INDs, CTNs, and other clinical trial authorizations.
- Lead regulatory planning for submissions, amendments, annual maintenance, and study closeout.
- Advise on country-specific requirements and submission pathways.
- Assess protocol amendment impact and classify amendments (substantial vs. non-substantial).
- Ensure submission timelines support clinical development milestones.
- Ensure submission packages are scientifically sound, complete, and compliant.
Qualifications:
- Bachelor’s degree.
- 5+ years of Regulatory Affairs experience in pharma/biotech.
Required Skills:
- Experience creating/managing global CTAs, CTNs, INDs, and other clinical trial authorizations.
- Strong organizational/planning skills; able to meet tight deadlines; detail-oriented, flexible, self-starter.
- Excellent collaboration across functional areas.
- Proficient with MS Office; Adobe Acrobat; Veeva Vault.
Nice to have:
- PhD/PharmD/MD/MS.
Work Details:
- Fully remote; occasional travel (~10%).
- Pay range: $164,000–$213,000 annual.
Application instructions:
- Current Insmed employees: apply via Jobs Hub in Workday.
Responsibilities:
- Lead planning, execution, and oversight of global regulatory activities supporting clinical trial applications and maintenance across the product development lifecycle.
- Serve as primary regulatory lead for global clinical trial submissions; ensure timely regulatory approvals for assigned regions (US, Canada, LATAM, APAC, and others).
- Provide regulatory leadership during agency interactions; manage regulatory questions and information requests.
- Coordinate cross-functional responses to enable timely initiation and conduct of global clinical trials.
- Develop and execute global regulatory strategies for CTAs, INDs, CTNs, and other clinical trial authorizations.
- Lead regulatory planning for submissions, amendments, annual maintenance, and study closeout.
- Advise on country-specific requirements and submission pathways.
- Assess protocol amendment impact and classify amendments (substantial vs. non-substantial).
- Ensure submission timelines support clinical development milestones.
- Ensure submission packages are scientifically sound, complete, and compliant.
Qualifications:
- Bachelor’s degree.
- 5+ years of Regulatory Affairs experience in pharma/biotech.
Required Skills:
- Experience creating/managing global CTAs, CTNs, INDs, and other clinical trial authorizations.
- Strong organizational/planning skills; able to meet tight deadlines; detail-oriented, flexible, self-starter.
- Excellent collaboration across functional areas.
- Proficient with MS Office; Adobe Acrobat; Veeva Vault.
Nice to have:
- PhD/PharmD/MD/MS.
Work Details:
- Fully remote; occasional travel (~10%).
- Pay range: $164,000–$213,000 annual.
Application instructions:
- Current Insmed employees: apply via Jobs Hub in Workday.