Senior Regulatory Affairs Specialist

Senior CMC Consultant (Biologics) – Remote

Are you a seasoned CMC professional with a passion for biologics and advanced therapies? A leading regulatory consultancy is seeking a Senior CMC RA Consultant to support global regulatory submissions for biologic and cell & gene therapy products.

Key Responsibilities:

• Author high-quality CMC regulatory documents (Module 3) aligned with various development stages.
• Prepare and deliver meeting requests, briefing packages, and responses to regulatory agencies.
• Review early-phase study designs for compliance with regulatory expectations.
• Assess manufacturing and quality changes for regulatory impact and prepare comparability reports.

Requirements:

• Master’s degree in a life science field (or equivalent experience).
• 5-10 years in industry focussing on CMC regulatory or 3–5 years within a regulatory authority.
• Strong knowledge of FDA/EMA biologic product regulations and GMP standards.
• Demonstrated excellence in writing clear, compliant, and well-structured CMC documentation.
• Self-driven, detail-oriented, and adept at managing multiple projects independently.
• Strong collaboration and communication skills.

This is a dynamic opportunity to work on innovative therapeutic programs while enjoying the flexibility of a remote position. You’ll be part of a collaborative team helping bring life-saving therapies to patients worldwide.