GRA CMC Lead

About This Role

This role drives global regulatory strategies for Sanofi's pharmaceutical and vaccine products, collaborating with cross-functional teams to navigate complex regulatory landscapes and optimize product development and manufacturing processes. The GRA CMC Lead will directly influence drug approval success through strategic negotiations with health authorities worldwide.

Responsibilities

• Guide products from early development to market by creating regulatory strategies and working directly with health authorities like FDA and EMA
• Identify potential challenges early, develop practical solutions, and help teams navigate complex regulatory requirements
• Work closely with diverse teams across R&D, Manufacturing, and Quality, fostering partnerships that drive success
• Assess risks and opportunities for pharmaceutical products, helping teams make informed choices that balance innovation with compliance
• Ensure regulatory submissions meet high standards by reviewing technical documents and providing strategic guidance to teams
• Keep up with evolving regulations and industry trends, helping Sanofi anticipate and adapt to new requirements
• Influence product development strategies and grow expertise in a supportive, inclusive environment

Requirements

• Minimum 4+ years of CMC regulatory experience
• Contributions to regulatory filings and implementation of regulatory strategies
• Experience responding to Health Authority questions
• Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field)
• Experience preparing regulatory documentation
• Familiarity with standard submission processes
• Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets
• Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams
• Strong written and verbal communication skills
• Fluency in English
• Capability to manage multiple projects in a fast-paced environment

Qualifications

• Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field)
• Minimum 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.

Benefits