Overview
Regulatory Affairs Manager, CMC Development Jobs in Petrolia, Canada at GE HealthCare
Title: Regulatory Affairs Manager, CMC Development
Company: GE HealthCare
Location: Petrolia, Canada
Category:
Location: Petrolia
Join a dynamic team as a Regulatory Affairs Manager focused on CMC. Leverage your expertise in radiopharmacy to influence global regulatory strategies for cutting-edge radiopharmaceutical products.
This pivotal role demands a strong background in regulatory affairs with at least 3 years of experience in CMC for marketed and clinical products. You will collaborate cross-functionally with CMC, QA, and manufacturing teams to ensure compliance and support post-approval changes. Key responsibilities include guiding project teams in submission strategies and authoring CMC documents to facilitate timely regulatory submissions.
Key Responsibilities:
• Define submission strategy documents and required data
• Author and review CMC dossier sections
• Provide regulatory input for assigned projects/products
• Maintain registration tracking information
• Collaborate with global regulatory teams on inquiries
Requirements:
• Advanced degree in pharmacy or related field
• Minimum 3 years in Regulatory Affairs or Quality
• Familiarity with PET production and GMP requirements
• Strong problem-solving and communication skills
• Experience with regulatory submissions for radiopharmaceuticals
Drive regulatory compliance with your expertise, guiding projects through complex CMC landscapes effectively.
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