Manager, Regulatory Affairs, Tactical Implementation

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.

What You'll Do:

• 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

Who You Are:

You have a Bachelor's degree along with 5+ years of experience in Regulatory Affairs in the pharmaceutical or biotechnology industry.

You also have:

• 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 have (but not required):

• Preferred experience in SmartSheet or other project management software

Who You Are:

Pay Range:
$133,000.00-173,000.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.