Manager, Regulatory Affairs - Tactical Implementation
Insmed Incorporated
August 07, 2026
Remote
United States
Corporate Functions
Manager, Regulatory Affairs, Tactical Implementation (Regulatory Affairs)
Responsibilities:
- Support tactical implementation: project timeline planning and documentation workflow management for global regulatory documents (INDs/CTAs, NDA/BLAs, MAAs, amendments/annual reports).
- Author/oversee preparation of regulatory documents and meeting materials (meeting requests, briefing books, cover letter forms), ensuring clarity/accuracy/consistency.
- Lead document workflows across lifecycles: creation, review, approval, revision, distribution, and archival.
- Prepare/organize agency comments and manage/track planned responses.
- Partner with Regulatory Strategists; serve as point of contact for Clinical, Nonclinical, and CMC to coordinate regulatory deliverables.
- Monitor new regulations/guidelines to maintain compliance.
- Improve regulatory systems, tools, and procedures to enhance efficiency and quality.
- Maintain submissions/correspondence and archive regulatory files using Veeva Vault Document Management System.
Qualifications:
- Bachelor’s degree.
- 5+ years of Regulatory Affairs experience in pharmaceutical or biotechnology.
Required Skills:
- Organizational/time management; ability to manage multiple projects and meet deadlines.
- Knowledge of regulations and guidances.
- Excellent written/verbal communication.
- Detail-oriented, flexible, self-starter.
- Ability to work in document repositories/sharing databases.
- Proficient in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.
Nice to Have:
- Preferred experience with SmartSheet or other project management software.
Work/Travel:
- Fully remote; occasional travel (~15%).
Pay Range:
- $133,000–$173,000 annually.
Responsibilities:
- Support tactical implementation: project timeline planning and documentation workflow management for global regulatory documents (INDs/CTAs, NDA/BLAs, MAAs, amendments/annual reports).
- Author/oversee preparation of regulatory documents and meeting materials (meeting requests, briefing books, cover letter forms), ensuring clarity/accuracy/consistency.
- Lead document workflows across lifecycles: creation, review, approval, revision, distribution, and archival.
- Prepare/organize agency comments and manage/track planned responses.
- Partner with Regulatory Strategists; serve as point of contact for Clinical, Nonclinical, and CMC to coordinate regulatory deliverables.
- Monitor new regulations/guidelines to maintain compliance.
- Improve regulatory systems, tools, and procedures to enhance efficiency and quality.
- Maintain submissions/correspondence and archive regulatory files using Veeva Vault Document Management System.
Qualifications:
- Bachelor’s degree.
- 5+ years of Regulatory Affairs experience in pharmaceutical or biotechnology.
Required Skills:
- Organizational/time management; ability to manage multiple projects and meet deadlines.
- Knowledge of regulations and guidances.
- Excellent written/verbal communication.
- Detail-oriented, flexible, self-starter.
- Ability to work in document repositories/sharing databases.
- Proficient in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.
Nice to Have:
- Preferred experience with SmartSheet or other project management software.
Work/Travel:
- Fully remote; occasional travel (~15%).
Pay Range:
- $133,000–$173,000 annually.