Regulatory Affairs Specialist

3 hours ago


Stirling, Stirling, United Kingdom Medpace, Inc. Full time

We are seeking an experienced Regulatory Affairs Specialist to join our UK team at Medpace, Inc. as a full-time, office-based employee.

About the Role:

This position plays a critical role in ensuring compliance with regulatory requirements and maintaining positive relationships with clients and internal stakeholders.

Key Responsibilities:
  • Manage clinical safety activities and multiple large programs, ensuring timely completion and high-quality deliverables.
  • Develop and maintain relationships with clients and internal stakeholders, providing expert safety knowledge and guidance.
  • Conduct thorough safety reviews of clinical study documents, including protocols, study reports, and marketing application components.
  • Create customized safety management plans based on client requirements.
Requirements:
  • Bachelor's degree or equivalent, supplemented by clinical safety experience, including project management and ideally line management experience.
  • Demonstrated experience in managing clinical safety activities for multiple programs.
  • Strong writing skills, with experience in creating departmental SOPs and Work Instructions.
  • Familiarity with PSMF generation and maintenance, as well as CCDS/RMP/SmPC writing and maintenance.
  • Comprehensive knowledge of global clinical safety regulatory requirements.
  • Excellent communication, leadership, and teamwork skills.
What We Offer:
  • A competitive salary range of £60,000 - £80,000 per year, commensurate with experience.
  • A dynamic and supportive work environment with opportunities for growth and professional development.
  • A comprehensive benefits package, including flexible work arrangements and employee wellness initiatives.


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