Senior Director, Regulatory Affairs
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Job Description
Senior Director of Regulatory Affairs overseeing global regulatory submissions for pharmaceuticals and drug-device products, ensuring compliance and marketing alignment. Collaborating with multiple departments and managing FDA interactions.
Responsibilities:
- Lead global regulatory submission management, publishing, and archiving for pharmaceutical and drug-device combination products
- Serve as the Regulatory Affairs Lead and subject matter expert for FDA regulated advertising and promotional materials
- Ensure compliant, efficient, and timely submissions to global health authorities (FDA, EMA, MHRA, etc.)
- Partner with marketing, legal, medical, and compliance to drive the Promotional Review Committee (PRC) for regulatory compliance with U.S. regulations
- Collaborate closely with Clinical, Manufacturing, Quality to ensure submission-readiness and alignment with regulatory timelines
- Communicate and coordinate with the FDA and manage regulatory aspects of quality systems
Requirements:
- Bachelor’s degree in Life Sciences required
- 15+ years of Regulatory Operations experience in the pharmaceutical, biotech, or medical device industry
- 5+ years specifically in FDA Advertising & Promotion
- Proven track record in planning, managing, and submitting global eCTD regulatory dossiers
- Deep knowledge of applicable regulations (FDA- Parts 11, 211, 820), ISO, EMA, ICH, Health Canada, MHRA) and industry best practices
- Hands-on experience with eCTD publishing tools and EDMS platforms (e.g., Veeva Vault RIM, Lorenz docuBridge, Extedo, etc.)
- Experience with combination products or devices regulated under both FDA/CDER and CDRH
- Familiarity with SPL submissions, XEVMPD, and IDMP initiatives
- Knowledge of RIM implementation and structured content authoring systems
- Ability to travel up to 20%
Benefits:
- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development
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