Role Summary
GRA CMC Lead within Sanofi's GRA CMC & GRA Device Organization, driving global regulatory strategies for pharmaceutical and vaccine products, collaborating with cross-functional teams to navigate complex regulatory landscapes, and directly influencing drug approvals through strategic negotiations with health authorities worldwide. Develop CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA across the product lifecycle. Collaborate with R&D, Manufacturing, and Quality teams while preparing regulatory submissions and anticipating regulatory trends to bring innovative therapies to patients 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: Identify potential regulatory challenges early, develop practical solutions, and help teams navigate complex requirements.
Build Strong Relationships: Collaborate with diverse teams across R&D, Manufacturing, and Quality to drive success.
Make Smart Decisions: Assess risks and opportunities for pharmaceutical products to balance innovation with compliance.
Drive Quality: Ensure regulatory submissions meet high standards by reviewing technical documents and providing strategic guidance.
Stay Ahead of Changes: Monitor evolving regulations and industry trends to anticipate and adapt to new requirements.
Lead with Impact: Influence product development strategies while growing expertise in a supportive, inclusive environment.
Qualifications
Required: Experience: Minimum 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
Required: Education: Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
Required: Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes.
Required: Technical Knowledge: Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets.
Required: Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams.
Required: Communication: Strong written and verbal communication skills, with fluency in English.
Required: 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 approximately 60% on-site presence.
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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: Identify potential regulatory challenges early, develop practical solutions, and help teams navigate complex requirements.
Build Strong Relationships: Collaborate with diverse teams across R&D, Manufacturing, and Quality to drive success.
Make Smart Decisions: Assess risks and opportunities for pharmaceutical products to balance innovation with compliance.
Drive Quality: Ensure regulatory submissions meet high standards by reviewing technical documents and providing strategic guidance.
Stay Ahead of Changes: Monitor evolving regulations and industry trends to anticipate and adapt to new requirements.
Lead with Impact: Influence product development strategies while growing expertise in a supportive, inclusive environment.
Qualifications
Required: Experience: Minimum 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
Required: Education: Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
Required: Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes.
Required: Technical Knowledge: Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets.
Required: Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams.
Required: Communication: Strong written and verbal communication skills, with fluency in English.
Required: 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 approximately 60% on-site presence.
#J-18808-Ljbffr