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CMC RA Senior Manager/AD China Submissions - Job Opportunity at Thermo Fisher Scientific

Remote, France
Full-time
Senior
Posted: May 11, 2025
Remote
USD 120,000 - 160,000 annually based on role seniority and market demand

Benefits

Professional development through award-winning learning programs
Comprehensive health and well-being package
Flexible work arrangements
Global career opportunities within 100,000+ organization
Collaborative work environment

Key Responsibilities

Lead CMC documentation preparation for China clinical and commercial dossiers
Direct CDE consultation meetings and regulatory interactions
Manage lifecycle of China dossiers for CMC compliance
Assess regulatory impact of CMC change controls
Oversee local QC testing coordination
Provide strategic input for CMC development
Coordinate with internal and external stakeholders
Track regulatory commitment execution

Requirements

Education

Master degree or PhD in biotechnology, pharmaceutical sciences or bio-engineering

Experience

Senior level experience in CMC development and regulatory affairs in China

Required Skills

Regulatory writing Knowledge of pharmacopoeial requirements ICH guidelines expertise China FDA and EMA/CHMP regulations understanding Team collaboration Multi-project management Detail-oriented Fluent English Proactive mindset
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on China market entry strategies in pharmaceutical industry Growing complexity in CMC regulatory requirements across global markets Rising demand for specialized regulatory expertise in large molecule therapeutics Trend toward harmonization of global regulatory standards while maintaining regional specificity

Role Significance

Likely leading a specialized team of 3-5 regulatory professionals with matrix management of global stakeholders
Strategic leadership position with direct impact on market entry success in China

Key Projects

Market authorization applications for novel therapeutics Clinical trial applications in China Post-approval variation management Regulatory strategy development for pipeline products

Success Factors

Deep understanding of China's evolving regulatory landscape Strong stakeholder management across cultural boundaries Strategic thinking in regulatory pathway planning Ability to balance global standards with local requirements

Market Demand

High demand due to expanding biopharmaceutical market in China and complex regulatory landscape

Important Skills

Critical Skills

China regulatory expertise specifically in CMC Strategic thinking and regulatory pathway planning Cross-cultural communication and stakeholder management Technical understanding of large molecule therapeutics

Beneficial Skills

Experience with global regulatory frameworks Project management certification Quality management systems knowledge Digital submission systems expertise

Unique Aspects

Combination of large molecule expertise with China regulatory focus
Integration of PPD clinical research capabilities with broader Thermo Fisher resources
Opportunity to shape regulatory strategy for novel therapeutics

Career Growth

2-4 years in role before advancement, depending on business growth and market expansion

Potential Next Roles

Global Head of Regulatory Affairs Director of International Regulatory Strategy VP of Regulatory Affairs Asia Pacific

Company Overview

Thermo Fisher Scientific

Thermo Fisher Scientific is a global leader in serving science with significant presence in pharmaceutical services through PPD clinical research portfolio

Fortune 500 company with strong market position in life sciences and diagnostic technologies
Strategic focus on China market expansion with significant investment in regulatory capabilities
Matrix organization emphasizing collaboration, innovation, and global teamwork with strong focus on professional development
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