Regulatory Operations Manager

Job Summary

We are seeking an experienced and detail-oriented Regulatory Operations Manager to support global regulatory submissions and operations for our 310 Start Program. The ideal candidate will have a strong background in regulatory processes, publishing, and submission management, with a keen understanding of global regulatory requirements. This role will coordinate closely with internal teams and CROs to ensure high-quality, timely regulatory filings across multiple regions, including the US, EU, and Canada.

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Responsibilities

• Lead and manage the planning, preparation, publishing, and submission of regulatory documents in compliance with regional and global health authority requirements.
• Coordinate regulatory activities with CROs, including submission timelines, amendments, and document management.
• Oversee and execute regulatory submissions such as INDs, CTAs, amendments, and annual reports.
• Support archiving and lifecycle management of regulatory documents and submission components for both US and global submissions (e.g., EMA, EU, Health Canada).
• Ensure timely and accurate regulatory filings across various stages of development.
• Maintain submission trackers, timelines, and status reports to ensure effective communication across project teams.
• Collaborate with cross-functional stakeholders to support the compilation and delivery of submission-ready documents.

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Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field.
• 2–4+ years of experience in regulatory operations within the pharmaceutical, biotech, or CRO industry.
• Demonstrated experience with regulatory submissions, publishing software/tools, and eCTD format.
• Knowledge of US FDA submission requirements; global experience (EMA, EU, Health Canada) is highly desirable.
• Strong organizational and project management skills with a proven ability to manage multiple priorities and meet deadlines.

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Interviews next week, apply today!