Sr. Manager, Regulatory CMC
March 29
Description
• Senior Manager, Regulatory CMC responsible for representing regulatory CMC on product teams • Develop and implement regulatory CMC strategies in a global regulatory environment • Prepare and review CMC submission documents, registration dossiers, and health authority packages • Provide input on establishing processes, policies, and tools for effective execution • Lead regulatory CMC compliance activities and quality initiatives • Interact with colleagues for delivery of quality regulatory materials • Support Regulatory Information Management by ensuring efficiency and compliance • Lead/participate in regulatory CMC infrastructure and capability building
Requirements
• BA/BS in life sciences, Chemistry, Biology, or other scientific discipline • 5+ years industry experience in biotech or pharma • 3 years directly in a Regulatory CMC role or with submission responsibilities • Technical expertise and knowledge of regulatory CMC requirements • Strong understanding of global regulatory CMC submission requirements • Ability to translate technical content into concise documents • Experience with global regulatory aspects of CMC programs • Strong written and oral communication skills • Experience with document management and Regulatory Information Management • Proficiency with MS Office tools
Benefits
• Defined regulatory CMC lead role • Opportunity to work with large and small molecule product teams • Involvement in the development of regulatory CMC strategies • Collaborate with stakeholders for global clinical development • Lead compliance activities • Interact with various departments for high-quality dossiers • Actively participate in regulatory CMC infrastructure building • Contribution to optimizing processes and cross-program learning
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