Career Opportunity
This is an exciting opportunity to take on a senior legal role and contribute to the growth of a new function in Europe.
Job Requirements
* Provide expert legal guidance to senior management and 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 product development and commercialization, import/export law, and environmental regulations.
* Develop and implement compliance strategies to ensure adherence to European regulatory requirements, including EU and international trade regulations, customs classifications, Incoterms, duty drawback processes, and trade sanctions.
* Collaborate with internal and external stakeholders, including government bodies, industry associations, and cross-functional teams, to address regulatory issues.
Key Responsibilities:
* Conduct investigations as directed.
* Support compliance audits, corrective actions, and continuous improvement initiatives.
* Assist in preparing and reviewing submissions to regulatory authorities such as the EMA, ECHA, or national agencies.
* 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.
* Train employees on regulatory requirements within the organization.