Policy & Regulatory Affairs Manager at Emerald AI influencing regulatory strategy and engaging with stakeholders. Analyzing policy developments and aligning business objectives with regulatory context.
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
Head of Compliance overseeing regulatory compliance for fintech company revolutionizing healthcare payments. Leading a high - performing compliance team ensuring adherence to evolving regulations.
IT Compliance Coordinator responsible for IT compliance and resilience across Hydro's operations. Overseeing projects, audits, and collaboration with IT and business stakeholders to ensure adherence to regulations and frameworks.
BIC Compliance Analyst ensuring compliance with risk management policies related to engagement letters and conflict waivers. Collaborating with partners and supporting firm attorneys with conflicts analysis.
Director, Global Regulatory Affairs leading Protara's ex - US regulatory strategy and operational execution for clinical studies in oncology, cell and gene therapy, and rare diseases.
Manager ensuring compliance across Regulatory, EHS, Product, and Data Governance domains at Celestica. Collaborating with suppliers and managing data integrity for compliance mandates.
Director of Regulatory Compliance managing compliance for cross - border payments fintech in Malta. Leading financial crime prevention and AML compliance efforts within the organization.
Compliance Associate managing client - specific tax forms at Oxford Risk Management Group. Responsibilities include data analysis and compliance reporting across various programs.
Senior Manager: Governance, Risk and Compliance leading GRC functions at Reward Gateway. Managing risk governance, regulatory compliance and assurance processes for the organization.
Manager of Audit & Compliance at Vectra responsible for internal audits of IT processes and compliance. Collaborating with IT, Security, Engineering teams to ensure effective risk management and regulatory compliance.