Insmed Incorporated · 7 hours ago
Manager, Regulatory Affairs, Tactical Implementation
Headquarters, NJ
Full-time
Onsite
Mid, Senior Level
$133K/yr - $173K/yr
5+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Manager, Regulatory Affairs, Tactical Implementation will be responsible for executing and overseeing global regulatory submission activities, ensuring compliance with regulatory requirements and internal standards while collaborating with cross-functional teams.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
Preferred
Preferred experience in SmartSheet or other project management software
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
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Will Lewis
Chairman and Chief Executive officer
Walter R. Perkins
Chief Technology Officer
Recent News
2026-01-13
Company data provided by crunchbase