Associate, Regulatory Operations

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 four 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 an Associate, Regulatory Affairs Operations on the Regulatory Affairs team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Operations, you'll be responsible for the publishing, management, and submission of regulatory documents in accordance with global health authority requirements. The role has a strong focus on eCTD publishing and document management within Veeva Submissions Vault, ensuring accuracy, compliance, and timely delivery of submissions to regulatory agencies.

What You'll Do:

• Prepare, compile, and publish regulatory submissions (INDs, NDAs, annual reports, supplements, amendments) in eCTD format using industry-standard publishing tools.
• Manage regulatory submission content and metadata within Veeva Submissions Vault, ensuring compliance with document management standards, version control, and audit readiness.
• Coordinate the intake, formatting, and QC of regulatory documents prior to submission.
• Ensure adherence to global regulatory authority technical requirements (FDA, EMA, Health Canada, MHRA, etc.) for electronic submissions.
• Maintain submission timelines, submission trackers, and regulatory archives.
• Partner with cross-functional teams (Regulatory Affairs, CMC, Clinical, Quality) to facilitate document authoring, review, approval, and publishing workflows.
• Conduct technical checks (validation, bookmarking, hyperlinking) to ensure submissions pass regulatory agency gateways.
• Support lifecycle management of submissions, including post-approval supplements, variations, and periodic reports.
• Provide training and guidance to internal teams on document management best practices.
• Contribute to process improvements and operational efficiencies in regulatory publishing and document management.

Who You Are:

You have a Bachelor's degree in Life Sciences, Pharmacy, Information Management, or related discipline, along with 1+ years of experience in regulatory operations or publishing within the pharmaceutical industry.

You are or you also have:

• Proficiency with Veeva Submissions Vault for document management and submission readiness.
• Hands-on experience with eCTD publishing tools (e.g., Lorenz, GlobalSubmit, Extedo, or equivalent).
• Strong knowledge of FDA, EMA, and ICH electronic submission standards and guidance.
• Excellent organizational skills, attention to detail, and ability to manage multiple projects with competing priorities.
• High technical aptitude for regulatory publishing and document management systems.
• Detail-oriented with strong focus on data integrity and compliance.
• Effective cross-functional communicator and collaborator.
• Ability to thrive under tight deadlines in a fast-paced environment.
• Continuous improvement mindset with interest in digital transformation of regulatory processes.

Where You'll Work

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.

Travel Requirements

Minimal travel expected

Pay Range:
$39.00-52.00 Hourly

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.

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.

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.