R&D GRA CMC Team Lead

R&D GRA CMC Team Lead

About the job

Our Team

The Global Regulatory Affairs GRA CMC & Device Organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls CMC and medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for pharmaceutical products, biologics, vaccines, and combination products, working closely with cross-functional partners to navigate complex regulatory landscapes. With a commitment to Sanofi's Take the Lead values, particularly in Leading Together and Being Bold, mission is to secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing innovative healthcare solutions to patients worldwide.

Main responsibilities

Strategic Leadership & Team Development

Provide oversight and leadership of a specialist sub-team within the CMC regulatory organization

Set clear expectations and performance objectives aligned with GRA goals

Foster an environment that promotes Taking the Lead behaviors and GRA Values

Global Regulatory Strategy Oversight

Oversee the development of global regulatory CMC strategies and risk assessments for development projects and marketed products

Ensure appropriate strategies for major CMC activities with critical regulatory and financial impact

Build and maintain internal/external relationships to achieve regulatory outcomes

Matrix Management Excellence

Enable effective matrix management between line organization and project Teams.

Establish clear roles and responsibilities between CMC Lead and Project Leads.

Coordinate with Project Leads on long-term resource planning

Regulatory Intelligence Leadership

Interpret global regulations and implement them within the team's work.

Identify and communicate regulatory paradigm shifts that impact the company.

Contribute knowledge to GRA Regulatory Science and Policy activities

Performance Management & Talent Development

Conduct regular performance evaluations and career development discussions

Identify skill gaps and create development opportunities through strategic project assignments

Work with Project Leads to identify and develop high-potential team members

Portfolio Management & Resource Optimization

Align team structure and capabilities with project portfolio needs.

Ensure balanced workload distribution among team members.

Collaborate with Project Leads to optimize resource allocation across projects

About you

Strong experience in pharmaceutical, CMC regulatory strategy experience, Expert-level understanding of CMC regulatory requirements across multiple regions

Advanced knowledge of drug development, manufacturing, and testing processes, Strong understanding of AI and its applications in regulatory affairs, Exceptional leadership and team development abilities, Strategic thinking and ability to drive organizational change, Advanced negotiation and influencing skills with global regulatory bodies e.g., FDA, EMA. Ability to manage complex, multi-stakeholder relationships & Proven ability to make high-impact decisions in ambiguous situations

Communication skills, Stakeholder management, Adaptability & flexibility, Critical thinking, Problem solving, Teamwork & collaboration, Time management, Emotional intelligence EQ, Compliance & quality mindset, Proactive ownership & Presentation skills

Strategic Thinking, Results-Oriented, People Leadership, Influencing, Others Regulatory Strategies, Product Registrations, Risk Management, Digital Adoption, Stakeholder Management & Advanced proficiency in MS Office Suite & Electronic document management systems Veeva vault, Plai