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Senior Manager II, Global CMC Regulatory Affairs

2 months ago

Kalamazoo, Michigan, United States Zoetis Full time
Position Overview:

As a key member of the Zoetis team, the Senior Manager II in Global Regulatory Affairs - CMC will oversee all regulatory aspects related to Chemistry, Manufacturing, and Control for a designated product portfolio. This role is integral to aligning with Zoetis' strategic objectives in veterinary drug development and managing regulatory changes effectively.

Key Responsibilities:
  • Act as the representative for the Zoetis Veterinary Medicine Research and Development Regulatory Affairs (VMRA) on all CMC-related matters, ensuring compliance with regulations from the FDA and other international regulatory authorities.
  • Prepare and present pre-approval product development plans for new experimental drugs to the FDA.
  • Compile and submit scientific dossiers for new experimental drugs to global health authorities, including the FDA and EMA.
  • Respond to scientific inquiries from regulatory agencies regarding both new and existing Zoetis products.
  • Maintain up-to-date knowledge of emerging global biopharma and pharmaceutical CMC regulations, contributing to the development of Zoetis' regulatory strategies.
  • Foster strong collaborative relationships with Zoetis manufacturing sites and contract manufacturing partners.
  • Coordinate with various functional departments within R&D, including formulation, analytical, clinical, and quality assurance, to guide research projects for new chemical entities (NCEs).
  • Serve as a liaison between R&D and other departments, including commercial strategy and corporate quality, to ensure alignment on project objectives.
  • Provide timely updates on project deliverables and communicate challenges to leadership teams.
  • Engage in negotiations and meetings with global health authorities regarding CMC-related product development and quality matters.
  • Develop innovative regulatory strategies for new product candidates and lifecycle management, ensuring compliance with global health authority requirements.
  • Advise Discovery and Early Development teams on regulatory direction and provide guidance to the Global Manufacturing organization on product manufacturing changes.
  • Monitor and communicate changes in regulatory policies and practices to relevant Zoetis departments.
Qualifications:

A Bachelor's degree in Chemistry, Biology, Chemical Engineering, Veterinary Medicine, Pharmaceutical Sciences, Regulatory Affairs, or a related field is required, along with a minimum of 10 years of relevant experience. Alternatively, a Master's degree in a related field with 8 years of experience will be considered.

This position may allow for telecommuting, with the expectation of reporting to the work site when necessary.