Senior Regulatory Analyst leading complex registrant compliance reviews for Alberta’s securities regulator. Advising firms, mentoring analysts, and supporting Canadian regulatory initiatives.
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Client Dedicated CMC Regulatory Manager/Senior Manager
Posted last month
About the role
- CMC regulatory leader guiding biologics submissions and lifecycle compliance for Thermo Fisher Scientific. Managing FDA and Health Canada dossiers, changes, and post-approval reporting.
Responsibilities
- Lead and execute global CMC regulatory strategy and submissions for biological products
- Provide CMC regulatory guidance for regulatory submissions to the FDA and Health Canada
- Liaise on CMC regulatory matters related to biologicals with R&D, Quality, Manufacturing, and Global Regulatory teams
- Oversee preparation, review, and submission of CMC sections (Module 3) for biological products, including MAAs and variations
- Author, compile, and maintain CTD Module 3 content
- Coordinate responses to CMC-related questions and deficiencies from Health Authorities
- Perform regulatory impact assessments for CMC change controls and quality events
- Lead preparation, authoring, review, and coordination of Annual Reports for U.S. and Canadian marketing applications
- Lead preparation, authoring, review, and coordination of Yearly Biologic Product Reports for Canadian marketing
- Author, review, and compile Module 1 documentation for commercial submissions in the U.S. and Canada
- Lead CMC regulatory management and dossier authoring for post-approval changes, manufacturing process changes, site transfers, and formulation updates
- Ensure continuous regulatory compliance throughout the biological product lifecycle
- Monitor and assess biologics regulatory guidance and provide strategic input into regulatory filings
Requirements
- Master's degree or PhD in biotechnology, pharmaceutical sciences or bioengineering
- Minimum 10 years of relevant expertise in CMC development and CMC regulatory for biological products
- Extensive knowledge of global regulations, including EMA regulations and ICH guidelines
- Knowledge of specific CMC regulatory requirements for biologics
- Proven 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 skills
- Strong communication and interpersonal skills
- Experience working in cross-functional and international teams
Benefits
- EEO/Affirmative Action protections
- Reasonable accommodation for individuals with disabilities
- Diverse experiences, backgrounds and perspectives valued
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