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Regulatory Affairs CMC Leader

2 months ago

Chalfont St Peter, Buckinghamshire, United Kingdom Lifelancer Full time
About the Role

We are seeking a highly skilled Regulatory Affairs CMC Manager to join our team at GE HealthCare Pharmaceutical Diagnostics (PDx). As the number one global supplier of contrast media and molecular imaging agents, we support three patients every second around the world.

Key Responsibilities
  • To be the regulatory CMC strategy point of contact for project teams and provide CMC related regulatory input for assigned projects/products.
  • Author and review individual CMC submission documents/CMC dossier sections to support regulatory submissions.
  • Support QA during audits and inspections as required.
Requirements
  • Bachelor's Degree in Chemistry, Pharmaceutical or Analytical Sciences.
  • Experience in pharmaceutical CMC or QA environment, particularly with injectable diagnostic or pharmaceutical products.
  • Knowledge of Quality Management Systems.
  • Some experience in Global Regulatory Affairs in the pharmaceutical industry.
  • Some experience with regulatory project management and regulatory agency interactions.
  • Demonstrated strong ability in written and verbal English.
  • Knowledge of international CMC regulatory requirements.
About the Company

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference.

Total Rewards

We offer competitive compensation and benefits to support your career growth and well-being. This role is based in Great Britain, United Kingdom, and relocation assistance is not provided.

About Lifelancer

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