Job Description

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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