Associate, Regulatory Operations

Role Summary

We’re looking for an Associate, Regulatory Operations on the Regulatory 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.

Responsibilities

• 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.

Qualifications

• Bachelor‚Äôs degree in Life Sciences, Pharmacy, Information Management, or related discipline, or High School Diploma/GED with 5+ years of experience in regulatory operations or publishing within the pharmaceutical industry.
• Proficiency with Veeva Submissions Vault for document management and submission readiness.
• Hands-on experience with eCTD publishing tools (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.

Skills

• Veeva Submissions Vault
• eCTD publishing
• Regulatory submissions standards (FDA/EMA/ICH)
• Document management and version control
• Cross-functional collaboration
• Attention to detail and data integrity

Education

• Bachelor‚Äôs degree in Life Sciences, Pharmacy, Information Management, or related discipline (or equivalent experience as noted in Qualifications).

Additional Requirements

• Remote work availability with occasional travel for team meetings or events; minimal travel expected.