Manager, Regulatory Affairs - Tactical Implementation

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 markets. 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.

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 Strategists 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.

Requirements

• Bachelor’s degree along with 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 databases.
• Proficient in MS Office applications (Word, Excel, PowerPoint, Outlook), Adobe Acrobat.

Nice To Have

• Preferred experience in SmartSheet or other project management software.

Schedule

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. This role requires occasional domestic/international travel (approximately 15%).

Pay

$133,000.00 - 173,000.00 Annual

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP).
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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, and meaningful opportunities to connect, volunteer, and give back.