Manager of Regulatory Affairs
Job Summary
To support innovative cell therapy development, the full-time Manager of Regulatory Affairs will manage regulatory strategies, submissions, and compliance while collaborating with cross-functional teams in a remote setting.
Key responsibilities
- Contribute to the development and execution of regulatory strategies aligned with corporate objectives and timelines
- Manage the preparation, review, and submission of regulatory documents including INDs/CTAs and BLAs
- Collaborate with Quality Assurance and Regulatory teams to ensure compliance with GXP regulations
Required qualifications
- Bachelor's or advanced degree in a relevant scientific field
- Minimum of 2-5+ years of experience in Regulatory Affairs within the biotechnology or pharmaceutical sector
- Extensive knowledge of regulatory requirements, including ICH and regional guidelines
- Experience with cell or gene therapy regulatory affairs
- Familiarity with CTD/eCTD and life cycle management
Complete Job Description
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