Associate, Regulatory Operations – Insmed
Insmed is seeking a proactive and detail-driven Associate, Regulatory Operations to support global regulatory submissions and documentation processes. As part of a mission-focused biopharmaceutical organization dedicated to improving the lives of patients with serious and rare diseases, this remote role plays a vital part in ensuring the accuracy, compliance, and timely delivery of regulatory submissions to global health authorities. The Regulatory Operations Associate position at Insmed Careers offers flexibility while contributing to impactful regulatory work. Apply for the Life Science Jobs Now!
Job Details:
- Job Title: Associate, Regulatory Operations
- Job ID: R2863
- Location: Remote (US-based)
- Department: Regulatory Operations
- Employment Type: Full-time
- Reports To: Executive Director, Regulatory Operations
- Posted: 4 Days Ago
- Travel: Minimal
- Compensation: $39.00–$52.00 per hour
About the Company:
Insmed is a global biopharmaceutical company committed to transforming the lives of patients with serious and rare diseases. Known for its strong people-first culture, Insmed has been recognized as Science Magazine’s No. 1 Top Employer for five consecutive years, certified as a Great Place to Work®, and named among the Best Places to Work in the UK. The company emphasizes curiosity, collaboration, inclusivity, and meaningful innovation.
Educational Requirements:
- Bachelor’s degree in Life Sciences, or related field with 1+ years of experience,
OR - High School Diploma/GED with 5+ years of experience in regulatory operations or publishing within the pharmaceutical industry.
Key Responsibilities of Regulatory Operations Associate:
- Prepare, compile, and publish regulatory submissions (INDs, NDAs, annual reports, amendments) in eCTD format.
- Manage submission content and metadata within Veeva Submissions Vault.
- Coordinate document intake, formatting, and quality checks before submission.
- Ensure adherence to FDA, EMA, Health Canada, MHRA, and other global regulatory standards.
- Maintain submission trackers, timelines, and regulatory archives.
- Collaborate with cross-functional teams (Regulatory, CMC, Quality, Clinical).
- Conduct technical validation, bookmarking, hyperlinking, and submission readiness checks.
- Support lifecycle management of post-approval submissions.
- Provide training on document management best practices.
- Participate in process improvement efforts related to regulatory operations.
Skills Required for the Regulatory Operations Associate Role:
- This Remote Role requires proficiency with Veeva Submissions Vault.
- Hands-on experience with eCTD publishing tools (Lorenz, GlobalSubmit, Extedo, etc.).
- Strong understanding of global electronic submission guidelines.
- Excellent organization, time management, and documentation skills.
- Ability to manage multiple priorities in a fast-paced regulatory environment.
- Strong attention to detail and commitment to data integrity.
- Effective communication and cross-functional collaboration skills.
- High technical aptitude and mindset for continuous improvement.
How to Apply?
Applicants interested for the Life Science Jobs must apply through the official Insmed careers portal. Candidates are encouraged to monitor their application status regularly and ensure all required documents are submitted according to regulatory hiring standards.
