Client Dedicated CMC Regulatory Manager/Senior Manager

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Lead and implement global CMC regulatory strategies and submissions for biological products.

• Provide guidance on CMC regulatory matters for submissions to the FDA and Health Canada.

• Collaborate on CMC regulatory issues related to biologicals with R&D, Quality, Manufacturing, and Global Regulatory teams.

• Manage the preparation, review, and submission of CMC sections (Module 3) for biological products, including MAAs and variations.

• Write, compile, and maintain content for CTD Module 3.

• Coordinate responses to CMC-related inquiries and deficiencies from Health Authorities.

• Conduct regulatory impact assessments for CMC change controls and quality events.

• Lead the preparation, authorship, review, and coordination of Annual Reports for U.S. and Canadian marketing applications.

• Direct the preparation, authorship, review, and coordination of Yearly Biologic Product Reports for Canadian marketing.

• Write, review, and compile Module 1 documentation for commercial submissions in the U.S. and Canada.

• Oversee CMC regulatory management and dossier authorship for post-approval changes, manufacturing process modifications, site transfers, and formulation updates.

• Ensure ongoing regulatory compliance throughout the lifecycle of biological products.

• Monitor and evaluate biologics regulatory guidance while providing strategic input into regulatory filings.

⛳️ Requirements

• Master's degree or PhD in biotechnology, pharmaceutical sciences, or bioengineering.

• A minimum of 10 years of relevant experience in CMC development and CMC regulatory for biological products.

• Comprehensive knowledge of global regulations, including EMA regulations and ICH guidelines.

• Familiarity with specific CMC regulatory requirements for biologics.

• Demonstrated experience leading CMC regulatory submissions for biological products, including initial MAA submissions and post-approval lifecycle management.

• Strong understanding of biologics manufacturing, characterization, comparability, and analytical testing requirements.

• Excellent project management abilities.

• Strong communication and interpersonal skills.

• Experience collaborating in cross-functional and international teams.

🏝️ Benefits

• EEO/Affirmative Action protections.

• Reasonable accommodations for individuals with disabilities.

• Diverse experiences, backgrounds, and perspectives are valued.