Associate, Regulatory Operations

Role Summary

Associate, Regulatory Operations. This role focuses on publishing, managing, and submitting regulatory documents in accordance with global health authority requirements, with a strong emphasis on eCTD publishing and document management within Veeva Submissions Vault.

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

• Required: Bachelor‚Äôs degree in Life Sciences, Pharmacy, Information Management, or related discipline, with 1+ years of experience in regulatory operations or publishing within the pharmaceutical industry.
• Preferred: Proficiency with Veeva Submissions Vault for document management and submission readiness.
• Preferred: Hands-on experience with eCTD publishing tools (e.g., Lorenz, GlobalSubmit, Extedo, or equivalent).
• Preferred: Strong knowledge of FDA, EMA, and ICH electronic submission standards and guidance.
• Preferred: Excellent organizational skills, attention to detail, and ability to manage multiple projects with competing priorities.
• Preferred: High technical aptitude for regulatory publishing and document management systems.
• Preferred: Detail-oriented with strong focus on data integrity and compliance.
• Preferred: Effective cross-functional communicator and collaborator.
• Preferred: Ability to thrive under tight deadlines in a fast-paced environment.
• Preferred: Continuous improvement mindset with interest in digital transformation of regulatory processes.

Skills

• Regulatory publishing and document management
• eCTD submission preparation and tooling
• Cross-functional collaboration
• Attention to detail and data integrity
• Project management and time management
• Technical proficiency with publishing systems

Education

• Bachelor‚Äôs degree in Life Sciences, Pharmacy, Information Management, or related discipline

Additional Requirements

• Location: Fully remote role; occasional travel for team meetings or events may be required.
• Travel: Minimal