Senior Counsel - EU Product & Chemical Regulatory Compliance

• Provide expert legal advice and guidance to senior management and legal colleagues on European regulations, directives, and policies impacting the business, including REACH, CLP, MDR/IVDR, GMP guidelines, pharmaceutical and/or medical device law, regulations, and guidance related to the development of and commercialization of products, import/export law and environmental regulations
• Engage with regulatory authorities (i.e. EMA, ECHA, NCAs), draft regulatory responses, facilitate audits, and advocate for the company in policy discussions
• Develop and implement compliance strategies to ensure adherence to European regulatory requirements, including adherence to EU and international trade regulations, including customs classifications, Incoterms, duty drawback processes, and trade sanctions
• Direct support for compliance audits, corrective actions, and continuous improvement initiatives
• Assist in the preparation and review of submissions to regulatory authorities such as the EMA, ECHA, or national agencies
• Collaborate with internal and external stakeholders, including government bodies, industry associations, and cross-functional teams, to address regulatory issues
• Develop and implement internal policies and procedures to ensure ongoing compliance with evolving regulations
• Stay updated on legislative changes and industry trends, assessing their impact on the organization and recommending proactive measures
• Identify and mitigate legal risks related to regulatory compliance, including field actions
• Conduct training sessions to enhance awareness of regulatory requirements within the organization

• Law degree (LLM or equivalent) and registered as an attorney in at least one European jurisdiction
• 10+ years of legal experience, preferably from working for a leading law firm and/or multinational corporation, with 5-7 years of experience specializing in European regulatory law within the pharmaceutical, chemical, medical device, or other highly regulated industries
• Experience collaborating across a matrixed business and legal environment
• In-depth knowledge of EU regulatory frameworks, including CLP, REACH, and GMP guidelines
• Strong analytical and problem-solving abilities, excellent communication and negotiation skills, and the ability to work effectively in cross-functional teams
• Proficiency in English is required and at least one other European language is preferred

At least one other European language