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

Remote, United Kingdom
Full-time
Senior
Posted: May 11, 2025
Remote
USD 120,000 - 160,000 per year based on role seniority and market demand

Benefits

Competitive compensation package aligned with industry standards
Award-winning learning and development program
Comprehensive health and well-being benefits
Flexible working arrangements
Global career development opportunities

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
Oversee regulatory impact assessment and variation filing strategy
Coordinate local QC testing activities
Provide strategic input into CMC development
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 expertise Knowledge of pharmacopoeial requirements Understanding of ICH guidelines Familiarity with China, FDA and EMA/CHMP regulations Team collaboration abilities Multi-project management Detail-oriented approach Self-initiative and proactive mindset Fluent English proficiency
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on China market access for global pharmaceutical companies requiring specialized regulatory expertise Growing complexity in CMC requirements for biological products driving demand for experienced professionals Shift towards harmonization of global and Chinese regulatory requirements creating opportunities for strategic roles

Role Significance

Likely leads a team of 3-5 regulatory professionals with matrix management across global CMC teams
Senior leadership position with strategic influence on market access and product lifecycle management

Key Projects

China market entry strategy development for novel therapeutics Regulatory agency negotiations and scientific advice meetings CMC change management and variation strategies Post-approval lifecycle management initiatives

Success Factors

Deep understanding of China's regulatory landscape and its evolution Ability to navigate complex stakeholder relationships across global teams Strategic thinking in regulatory pathway planning Excellence in technical documentation and scientific communication

Market Demand

High demand due to expanding biopharmaceutical sector in China and limited pool of experienced CMC regulatory professionals

Important Skills

Critical Skills

China regulatory expertise with focus on CMC requirements Strategic thinking and regulatory pathway planning Cross-cultural communication and stakeholder management

Beneficial Skills

Experience with multiple regulatory frameworks Project management certification Knowledge of emerging regulatory trends

Unique Aspects

Direct involvement in China's evolving regulatory landscape
Opportunity to shape regulatory strategy for novel therapeutics
Integration of global and local regulatory requirements

Career Growth

2-4 years in role before advancement opportunity, depending on business growth and performance

Potential Next Roles

Global Head of CMC Regulatory Affairs Regional Regulatory Affairs Director VP of Regulatory Affairs

Company Overview

Thermo Fisher Scientific

Global leader in serving science with significant presence in clinical research services through PPD acquisition

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
Innovation-driven environment with emphasis on professional development and global collaboration
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