Regulatory Affairs Professional

3 days ago


London, Greater London, United Kingdom Lifelancer Full time
Job Overview

Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.

Key Responsibilities

The role of Global Regulatory Support Specialist involves managing clinical trial applications to Competent Authorities, Ethics Committees, and Regulatory Agencies. You will be responsible for the day-to-day activities and delivery of global regulatory affairs support services.

Responsibilities:
  • Manage clinical trial applications, regulatory filings/submissions/revisions, and coordinate daily delivery of regulatory services and processes.
  • Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on clinical research regulatory requirements and industry best practices.
  • Provide regulatory, ethics, and pharmacovigilance guidance and support to project stakeholders, representing the unit at project meetings and assisting with project education/regulatory tool development.
  • Identify changes in clinical research regulatory requirements and recommend, implement, and maintain corporate regulatory strategies to meet compliance requirements.
  • Participate in conferences/meetings to increase knowledge as needed, regularly respond to registration requests, and work with project teams to identify regulatory requirements.
Requirements

We are seeking a highly skilled professional with strong knowledge of EMA regulations and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.

Benefits

This is a home-based position offering a salary range of £42,500 - £71,000 per year.



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