Home Jobs CMC RA Senior Manager/Associate Director - China Submissions
Back to Jobs

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

China
Full-time
Senior
Posted: February 8, 2025
Remote
USD 120,000 - 180,000 annually based on China market rates for senior regulatory positions

Benefits

Comprehensive learning and development program
Work-life balance with flexible working culture
Competitive salary package
Global career opportunities within 100,000+ colleague network
Health and well-being focused benefits package

Key Responsibilities

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

Requirements

Education

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

Experience

Not explicitly stated but Senior/AD level implies 8+ years

Required Skills

CMC development expertise China regulatory affairs knowledge Excellent regulatory writing skills Knowledge of pharmacopoeial requirements ICH guidelines understanding FDA and EMA/CHMP regulations expertise Team collaboration abilities Multi-tasking capabilities Detail-oriented mindset Proactive attitude Fluent English proficiency
Advertisement
Ad Space

Sauge AI Market Intelligence

Industry Trends

Increasing focus on China market access for biotechnology products requiring specialized regulatory expertise Growing demand for CMC regulatory professionals with cross-border experience Shift towards more complex biological therapeutics requiring sophisticated CMC documentation Enhanced regulatory scrutiny in China's pharmaceutical sector driving need for experienced professionals

Role Significance

Likely leads a team of 3-5 regulatory specialists while coordinating with global CMC teams of 15-20 members
Strategic leadership position with direct impact on market access success in China

Key Projects

New therapeutic product registrations in China Post-approval CMC changes management Regulatory strategy development for novel biologics CDE consultation preparation and execution

Success Factors

Deep understanding of China's evolving regulatory landscape Ability to bridge global CMC requirements with China-specific regulations Strong stakeholder management skills across cultural boundaries Strategic thinking combined with technical expertise Excellent project management capabilities

Market Demand

Very high demand due to expanding biopharmaceutical sector in China and limited talent pool with combined CMC and regulatory expertise

Important Skills

Critical Skills

China regulatory expertise specifically for CMC Strategic thinking and risk assessment capabilities Cross-cultural communication skills Technical understanding of large molecule development

Beneficial Skills

Experience with multiple regulatory agencies Change management expertise Digital documentation systems knowledge Project management certification

Unique Aspects

Combination of CMC expertise with China regulatory focus is relatively rare
Role bridges global development with local registration requirements
Position offers exposure to novel therapeutic developments

Career Growth

2-4 years in role before progression, depending on business growth and market conditions

Potential Next Roles

Director of Regulatory Affairs Head of China Regulatory Operations Global CMC Strategy Lead Regional Regulatory Affairs Head

Company Overview

Thermo Fisher Scientific

Global leader in serving science with significant presence in clinical research and laboratory products

Fortune 500 company with strong market position in life sciences and diagnostics
Established presence in China with growing focus on biotechnology sector
Matrix organization emphasizing global collaboration with strong focus on scientific excellence
Advertisement
Ad Space
Apply Now

Data Sources & Analysis Information

Job Listings Data

The job listings displayed on this platform are sourced through BrightData's comprehensive API, ensuring up-to-date and accurate job market information.

Sauge AI Market Intelligence

Our advanced AI system analyzes each job listing to provide valuable insights including:

  • Industry trends and market dynamics
  • Salary estimates and market demand analysis
  • Role significance and career growth potential
  • Critical success factors and key skills
  • Unique aspects of each position

This integration of reliable job data with AI-powered analysis helps provide you with comprehensive insights for making informed career decisions.