CMC Regulatory professional at Zoetis preparing regulatory documentation and ensuring compliance with FDA and USDA regulations. Managing facility documents and participating in cross - functional project improvements.
About the role
- Environmental Risk Assessment Lead at Sanofi driving innovative environmental sustainability initiatives through regulatory compliance and cross-functional collaboration.
Responsibilities
- Lead Sanofi's Environmental Risk Assessment (ERA) program for new Marketing Authorization Applications (MAAs), ensuring compliance with global regulatory requirements (e.g., EMA, FDA) and internal standards.
- Design, implement, and continuously improve ERA processes, defining clear roles and responsibilities across GHSE, R&D, Regulatory Affairs, external consultants, and regulators (e.g., governance model, workflows, timelines).
- Serve as the ERA Subject Matter Expert, supporting MAA teams with technical oversight of study design, test monitoring, and data interpretation, and manage regulatory interactions, external consultants, and final ERA approvals.
- Support the development and implementation of global Eco-Pharmaco-Vigilance (EPV) and Pharmaceuticals in the Environment (PiE) risk assessment and mitigation strategies, in partnership with Global Business Units (e.g., strategic roadmap, product prioritization).
- Collaborate cross-functionally with Global Functions, Global Business Units, CSR, and Digital teams to strengthen environmental risk data collection, monitoring, and internal/external reporting (e.g., EPV dashboard, factsheets, CSRD).
- Support ESG and regulatory compliance data collection and reporting related to ecotoxicity and pollution parameters, and respond to emerging regulations (e.g., CSRD, UWWTD).
Requirements
- Advanced degree in a relevant scientific field (ecotoxicology, environmental science, or a related discipline).
- Proven expertise in Environmental Risk Assessment (ERA) and ecotoxicology within the pharmaceutical, biotech, or chemical industries, with a track record of improving environmental performance.
- Strategic thinker with hands-on project management skills.
- Excellent stakeholder management and communication skills, with the ability to collaborate effectively across functions.
- Self-driven with the ability to lead change autonomously.
- Strong analytical mindset with data visualization capabilities.
- Ability to translate complex technical information into clear executive summaries.
- Fluency in English is required; French is an advantage.
Benefits
- Make your work count by supporting a company that brings life-changing treatments to millions while committing to do right by patients, communities, and the planet.
- Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainable outcomes.
- Lead meaningful environmental impact by protecting both human health and planetary health through innovative Eco-Pharmaco-Stewardship programs.
- Work at the intersection of science, sustainability, and regulatory innovation, tackling emerging challenges such as antimicrobial resistance and microplastics.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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