Senior Manager, Regulatory Affairs
About The Position
The Senior Manager, Regulatory Affairs is responsible for managing regulatory activities supporting global clinical development programs across all phases. This role independently plans, prepares, and manages regulatory submissions, contributes to regulatory strategy development, and serves as a key regulatory representative on cross-functional teams. The Senior Manager partners with internal stakeholders to ensure timely, high-quality regulatory submissions that comply with global health authority requirements while supporting the successful execution of development programs. The ideal candidate has a strong understanding of global regulatory requirements, demonstrates sound regulatory judgment, and is capable of managing multiple complex projects with minimal supervision.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
- 5+ years of experience in the pharmaceutical or biotechnology industry with a strong focus on clinical development.
- Demonstrated experience preparing and managing global regulatory submissions, including INDs, CTAs, amendments, and annual reports.
- Working knowledge of global regulatory requirements and guidelines, including FDA, EMA, ICH, and GCP.
- Experience supporting health authority interactions and regulatory correspondence.
- Strong project management and organizational skills with the ability to manage multiple priorities independently.
- Excellent written and verbal communication skills with the ability to clearly communicate scientific and regulatory information.
- Demonstrated ability to work effectively in cross-functional teams and influence outcomes through collaboration.
Nice To Haves
- Experience with regulatory document management systems (e.g. Veeva Vault) is desirable.
Responsibilities
- Independently lead and coordinate the preparation, review, and submission of clinical regulatory documents (e.g., INDs, CTAs, amendments, annual reports).
- Contribute to the development and execution of regulatory strategies for clinical-stage programs.
- Collaborate with Clinical Operations, Medical Writing, and other internal functions to review and compile documentation for regulatory submissions (e.g., protocols, investigator brochures, clinical study reports).
- Review clinical development documents, including protocols, investigator brochures, informed consent forms, and clinical study reports, to ensure regulatory requirements are appropriately addressed.
- Identify regulatory risks and escalate issues with proposed solutions to regulatory management.
- Ensure regulatory submissions comply with applicable regulations, guidance documents, and internal standards.
- Coordinate submission timelines, deliverables, and regulatory activities to support development milestones.
- Contribute to health authority interactions, including the preparation of meeting briefing documents and responses to information requests.
- Evaluate emerging regulatory guidance and communicate relevant changes and potential impacts to project teams.
- Ensure accuracy and completeness of regulatory content in submission archives and tracking systems.
Benefits
- paid time off benefits
- health, vision, and dental insurance options
- 401(k) retirement benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
