Zoetis, Inc. Supports all regulatory Chemistry Manufacturing and Control aspects of an assigned product portfolio associated with Zoetis business objectives, veterinary drug development projects, regulatory change management and/or routine registration maintenance for the US and global region. Represents the Zoetis Veterinary Medicine Research and Development Regulatory Affairs (VMRA) organization on all chemistry, manufacturing and control (CMC) i.e. product development and compliance related matters for new experimental drugs and marketed products to the US- FDA or other international regulatory bodies. Job duties involve- Presentation of pre- approval product development plans on new experimental drugs/ products to the US- FDA. Preparing and submission of scientific dossiers of new experimental drugs to global health authorities like US- FDA, EMA (European Medicines Agency) etc. Responsible for responding to scientific queries. Maintains knowledge and awareness of emerging global biopharma and pharmaceutical CMC regulations and assists in the development of Zoetis regulatory positions and strategies. Develops strong working relationships with both Zoetis manufacturing sites and contract manufacturing interfaces for assigned portfolio. Works with VMRD Partner groups to ensure appropriate alignment and sharing of best regulatory/compliance practices. Responsible for responding to scientific queries received from the regulatory agencies worldwide (like the US- FDA, EMA, VDD etc.) on new experimental products as well as legacy Zoetis in- line products. Responsible for research projects at Zoetis for new chemical entities (NCEs) and for innovative platforms which involves multi functional teams. Job duties involve- Coordinating, directing, and guiding multiple  functional departments resources within the R and D organizations like formulation, analytical, clinical, regulatory, statisticians, quality assurance, medicinal chemistry, sourcing and procurement, pharmaco-kinetic and pharmacodynamic, clinical safety and toxicological groups etc. Being a liaison between the R and D organization and the other arms of Zoetis like the commercial, corporate strategy and market research, manufacturing, corporate quality etc. Providing timely updates on deliverables and timelines as well as communicating project teams challenges/ hurdles to the Zoetis governance/ leadership teams. Responsible for negotiations and meetings with global Health Authorities on Chemistry, Manufacturing and control (CMC) i.e. product development and quality related matters for new experimental drugs/ products as well as legacy Zoetis in- line products topics. Work with regulatory, R and D and Global Manufacturing management in developing creative, cost-effective regulatory strategies for new product candidates, life cycle management candidates and in-line products to meet global Health Authority requirements. Some of the job duties involve- Provide regulatory direction and recommendation to Discovery and Early Development teams in the Zoetis R and D organization. Provide regulatory position and advice to the Zoetis Global Manufacturing organization for all Zoetis commercialized product manufacturing changes. Identify and communicate changes in Global Regulatory bodies/ authorities' policy, procedure or practice to Zoetis R and D, Zoetis Global Manufacturing and Zoetis Quality organizations. Bachelor's degree in Chemistry, Biology, Chemical Engineering, Veterinary Medicine, Pharmaceutical Sciences, Regulatory Affairs, or related and 10 years of experience required. In lieu of Bachelor's degree and 10 years, will accept a Master's degree in Chemistry, Biology, Chemical Engineering, Veterinary Medicine, Pharmaceutical Sciences, Regulatory Affairs, or related and 8 years of experience. Telecommuting may be permitted, when not telecommuting, must report to work site. To apply, email your resume to helen.ljubicich@zoetis.com and reference job #7796017