GE HealthCare Regulatory Affairs CMC Manager 

Remote, Remote 

93012619

As Regulatory Affairs CMC Manager (Chemistry, Manufacturing and Control) you provide regulatory input and strategies to directly support development projects and marketed products in our Contrast Media portfolio of Pharmaceutical Diagnostics. The key responsibility is to develop and maintain the Quality sections of the product dossiers throughout the entire life cycle of a product. The role requires strong technical knowledge and a good understanding of how sites and quality systems work. You will closely collaborate with global Supply Chain, Site Manufacturing and Quality teams in Europe, China and US. Candidates for this role are located near our site in Oslo or Chalfonts.

Key Responsibilities include:

• To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products.
• Author and review individual CMC submission documents/CMC dossier sections to support regulatory submissions.
• To support QA during audits and inspections as required.

Qualifications/Requirements

• Bachelor’s Degree, preferable in Chemistry, Pharmaceutical or Analytical Sciences;
• Experience in pharmaceutical CMC or QA environment in particular 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 in order to clearly and concisely present information targeted to the relevant audience.
• Knowledge of international CMC regulatory requirements.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support