Home Jobs CMC Project Manager- FSP
Back to Jobs

CMC Project Manager- FSP - Job Opportunity at Thermo Fisher Scientific

Remote, France
Full-time
Senior
Posted: April 26, 2025
Remote
EUR 80,000 - 110,000 per year based on location and experience level

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 and optimize CMC change control systems with direct impact on global regulatory compliance
Drive strategic project management of CMC lifecycle initiatives across multiple stakeholders
Develop and implement risk mitigation strategies for complex regulatory changes
Oversee cross-functional teams and facilitate critical decision-making processes
Maintain quality standards and regulatory compliance across international markets
Design and execute process improvement initiatives for change control systems

Requirements

Education

Bachelor or Master degree in Life Sciences, Pharmacy, Chemistry, or a related field. Advanced degree preferred

Experience

Minimum of 5 years of experience in the biopharmaceutical industry, with at least 3 years in a regulatory affairs or CMC role

Required Skills

In-depth knowledge of CMC regulatory requirements and guidelines (FDA, EMA, ICH) Project management expertise Strong organizational and analytical capabilities Advanced communication and interpersonal skills Detail-oriented quality focus
Advertisement
Ad Space

Sauge AI Market Intelligence

Industry Trends

Increasing complexity in global regulatory requirements is driving demand for experienced CMC professionals Digital transformation in regulatory operations is creating new opportunities for process optimization Growing focus on decentralized clinical trials is reshaping project management approaches Rise in biologics and advanced therapy medicinal products is expanding CMC scope

Role Significance

Typically leads cross-functional teams of 5-10 members with matrix management responsibilities
Senior individual contributor role with significant influence on regulatory strategy and compliance outcomes

Key Projects

Global regulatory change implementation programs CMC lifecycle management initiatives Quality system optimization projects Cross-functional compliance programs

Success Factors

Deep understanding of global regulatory landscape and ability to anticipate regulatory trends Strong stakeholder management skills across multiple organizational levels Strategic thinking combined with attention to technical detail Ability to balance multiple competing priorities while maintaining quality standards

Market Demand

High demand with growing competition for experienced CMC professionals due to expanding biopharma sector and increasing regulatory complexity

Important Skills

Critical Skills

Regulatory Strategy: Essential for navigating complex global requirements and ensuring compliance Project Management: Core to coordinating multiple stakeholders and delivering successful outcomes Quality Systems: Fundamental for maintaining compliance and driving continuous improvement Change Management: Critical for implementing new processes and ensuring adoption

Beneficial Skills

Digital Tools Proficiency: Growing importance for remote collaboration and process automation Data Analytics: Valuable for metrics tracking and process optimization Risk Management: Important for proactive issue identification and resolution Leadership Skills: Beneficial for team coordination and stakeholder management

Unique Aspects

Direct client dedication model allowing for deep specialization
Integration of PPD clinical research capabilities with broader Thermo Fisher resources
Opportunity to impact global health outcomes through regulatory excellence
Exposure to cutting-edge clinical research methodologies

Career Growth

2-4 years in role before advancement, depending on project portfolio success and organizational growth

Potential Next Roles

Senior CMC Program Manager Head of Regulatory Affairs Director of Technical Operations Global Change Control Lead

Company Overview

Thermo Fisher Scientific

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

Industry leader with over 100,000 employees and extensive global reach in clinical research services
Strong European presence with significant investment in remote work capabilities
Professional environment focused on scientific excellence with emphasis on collaboration and continuous learning
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.