Regulatory Affairs Manager
Overview:
A growing biopharmaceutical company is seeking a Regulatory Affairs Manager to lead strategic regulatory operations across the U.S., Canada, and other global markets. This is a high-impact leadership role responsible for overseeing regulatory submissions, compliance, and strategy for biologics and medical devices.
Key Responsibilities:
- Lead preparation and submission of regulatory filings (INDs, BLAs, 510(k)s, etc.) in eCTD format
- Manage communications with regulatory agencies including FDA, Health Canada, and USDA
- Oversee promotional and advertising material review and submission
- Provide regulatory guidance on product development and lifecycle management
- Collaborate cross-functionally with Quality, R&D, Manufacturing, and Commercial teams
- Monitor regulatory changes and ensure ongoing compliance
- Lead and mentor the regulatory team, driving performance and professional growth
- Support budgeting and resource planning for the regulatory department
Qualifications:
- 5+ years of regulatory affairs experience in biologics and/or medical devices
- Strong knowledge of FDA, Health Canada, USDA regulations
- Experience with eCTD submissions and promotional review
- Proven leadership and team management experience
- RAC certification preferred
- Bachelor's degree in a scientific discipline required
Why Apply?
This is an opportunity to make a direct impact on regulatory strategy and product success within a mission-driven organization focused on improving patient outcomes through innovative immunotherapy solutions.
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