GRA CMC Lead

Role Summary

GRA CMC Lead in Morristown, NJ. You will drive global regulatory strategies for pharmaceutical and vaccine products within the GRA CMC & GRA Device Organization, collaborating with cross-functional teams to navigate complex regulatory landscapes and optimize development and manufacturing processes. You will influence drug approvals through strategic negotiations with health authorities worldwide.

Responsibilities

• Shape the Future of Medicine: Guide products from early development to market by creating smart regulatory strategies and working directly with health authorities like FDA and EMA.
• Be a Problem Solver: Use your expertise to spot potential challenges early, develop practical solutions, and help teams navigate complex regulatory requirements.
• Build Strong Relationships: Work closely with diverse teams across R&D, Manufacturing, and Quality, fostering partnerships that drive success.
• Make Smart Decisions: Assess risks and opportunities for pharmaceutical products, helping teams make informed choices that balance innovation with compliance.
• Drive Quality: Ensure regulatory submissions meet high standards by reviewing technical documents and providing strategic guidance to teams.
• Stay Ahead of Changes: Keep up with evolving regulations and industry trends, helping Sanofi anticipate and adapt to new requirements.
• Lead with Impact: Use your voice to influence product development strategies, while growing your expertise in a supportive, inclusive environment.

Qualifications

• Experience: Minimum 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
• Technical Knowledge: Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets.
• Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams.
• Communication: Strong written and verbal communication skills, with fluency in English.
• Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.

Education

• Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).

Additional Requirements

• Hybrid work environment with on-site expectations (60% on-site).