Regulatory Affairs Director

4 weeks ago


Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full time

This role involves leading proactive monitoring and surveillance on changes in the global regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. This is a 7-month contract role.

Main Responsibilities
  • Regulatory Environment Monitoring: Monitor and analyze the external regulatory environment, including guidelines and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders.
  • Reg Intel Systems Oversight: Lead the comprehensive day-to-day oversight and management of Reg Intel Systems and Dashboards – Ensure seamless operation, maintenance, and continuous improvement of these tools, which are needed for monitoring and analyzing regulatory trends and compliance requirements.
  • Collaboration and Communication: Work closely with cross-functional teams, including IT, GDS, compliance, regulatory affairs, and other functions as well as external vendors to ensure that the Reg Intel Systems and dashboards are aligned with organizational goals and regulatory requirements.
  • Stakeholder Management: Identify business-critical aspects and communicate effectively to internal stakeholders.
  • Regulatory Intelligence Alignment: Collaborate with cross-functional teams to align regulatory intelligence with business objectives.
  • Process Improvement: Lead cross-functional teams to streamline Regulatory Intelligence-related processes and improve operational efficiency.
  • Regulatory Compliance: Implement best practices and innovative solutions to enhance regulatory compliance and efficiency.
  • Training and Support: Provide ongoing support and training to users of the Reg Intel Systems and dashboards. Develop comprehensive training materials and conduct workshops to ensure that all users are proficient in utilizing these tools to their full potential.
  • Regulatory Intelligence Support: Support project teams, functions, and departments through the collection and distribution of requested regulatory intelligence information.

Regeneron Pharmaceuticals Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.



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