Manager, Regulatory Affairs - Tactical Implementation
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 a Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs, Tactical Implementation, you’ll have a critical role in hands-on execution and oversight of global regulatory submission activities across assigned programs and market. Under the guidance of the Associate Director, you will ensure high-quality, timely, and compliant preparation and delivery of regulatory documentation throughout product lifecycles. You will work closely with Regulatory Strategists bridging regulatory strategy and operational execution, while supporting cross-functional teams to ensure alignment with global regulatory requirements and internal standards.
Requirements
- Bachelor’s degree
- 5+ years of experience in Regulatory Affairs in the pharmaceutical or biotechnology industry
- Excellent organizational and time management skills to manage multiple ongoing projects simultaneously to meet tight deadlines
- Knowledge and understanding of regulations and guidances
- Excellent communications skills (written and verbal)
- Efficient, detail-oriented, flexible, and a self-starter
- Able to work in different document repository and sharing database
- Proficient in MS Office applications (Word, Excel, PowerPoint, Outlook), Adobe Acrobat
Nice To Haves
- Preferred experience in SmartSheet or other project management software
Responsibilities
- Support aspects of tactical implementation for assigned projects including project timeline planning and documentation workflow management for global regulatory documents (including but not limited to INDs/CTAs, NDA/BLAs, MAA, amendments annual reports) in alignment with established timelines, regulatory requirements, and internal quality standards
- Author and oversee the preparation of regulatory documents and meeting materials (e.g., meeting requests, briefing books, cover letter forms, etc.) ensuring clarity, accuracy, and consistency
- Lead document workflows throughout document lifecycles for regulatory documents, including creation, review, approval, revision, distribution, and archival
- Assist in preparing and organizing all comments received from regulatory agencies and manage and/or track the company’s planned response
- Partner with Regulatory Strategies and act as a point of contact for cross-functional teams (e.g., Clinical, Nonclinical, CMC) to ensure effective coordination and execution of regulatory deliverables
- Monitor new regulations and guidelines to ensure internal processes and deliverables remain compliant
- Contribute to the development and improvement of regulatory systems, tools, and procedures to enhance efficiency and quality
- Maintain submissions and correspondence and archive regulatory files using Veeva Vault Document Management System
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
Manager
