Regulatory Affairs CMC Manager

Job title:

Regulatory Affairs CMC Manager

Company

GE HealthCare

Job description

Job Description Summary 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.Job DescriptionGE 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, and every difference builds a healthier world.GE HealthCare Pharmaceutical Diagnostics (PDx) is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.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.

BehaviorsWe expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.Total RewardsOur 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 supportInclusion & DiversityGE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.#LI-WRO#OnsiteAdditional InformationRelocation Assistance Provided: No

Expected salary

Location

Oslo

Job date

Fri, 29 Nov 2024 07:06:21 GMT

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