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," our 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
List here ideally the must-haves criteria to be successful on the role. Don’t forget: the less criteria you will request, the more diverse candidates you will get in the pool.
Experience 15-17 Years , 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
Soft skills Communication skills, Stakeholder management, Adaptability & flexibility, Critical thinking, Problem solving, Teamwork & collaboration, Time management, Emotional intelligence (EQ), Compliance & quality mindset, Proactive ownership & Presentation skills
Technical 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)
Languages English
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
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We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
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