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

Remote, France
Full-time
Senior
Posted: March 10, 2025
Remote
USD 120,000 - 160,000 annually based on role seniority and market demand

Benefits

Award-winning learning and development program
Comprehensive health and wellbeing package
Flexible working culture with work-life balance focus
Global career development opportunities
Collaborative team 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
Oversee local QC testing coordination
Strategic assessment of regulatory impacts
Coordinate with global partners on deliverables
Track and ensure 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 Project management skills English fluency Detail-oriented mindset
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on China market access for biopharmaceuticals requiring specialized regulatory expertise Growing complexity in CMC requirements for biological products across global markets Rise in demand for regulatory professionals with cross-border expertise Shift towards harmonized global regulatory frameworks while maintaining regional specificity

Role Significance

Typically leads a team of 3-5 regulatory specialists while coordinating with global cross-functional teams
Strategic leadership position with direct influence on market access decisions and regulatory strategy

Key Projects

Commercial dossier development for novel biologics Regulatory strategy development for China market entry Post-approval change management CDE consultation preparation and execution

Success Factors

Deep understanding of China's evolving regulatory landscape Ability to navigate complex stakeholder relationships across global teams Strategic thinking in regulatory planning and risk assessment Strong project management capabilities with attention to detail

Market Demand

High demand due to expanding biopharma presence in China and complex regulatory landscape

Important Skills

Critical Skills

China regulatory framework expertise - essential for market access strategy CMC technical knowledge - crucial for dossier development Strategic thinking - vital for lifecycle management Cross-cultural communication - key for global team effectiveness

Beneficial Skills

Experience with multiple regulatory frameworks Understanding of drug development process Digital documentation systems expertise Change management capabilities

Unique Aspects

Direct involvement in China's growing biopharmaceutical market
Combination of technical CMC expertise with regulatory strategy
Global reach with local market focus
Integration of PPD clinical research capabilities

Career Growth

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

Potential Next Roles

Global Regulatory Affairs Director Head of APAC Regulatory Affairs VP of Regulatory Affairs

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 biotech and pharmaceutical services
Strategic focus on China market expansion with established global infrastructure
Innovation-driven environment with emphasis on professional development and global collaboration
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