Regulatory CMC Senior Associate II

Job description

POSITION RESPONSIBILITIES: The successful candidate will support all regulatory CMC aspects of an assigned product portfolio associated with Zoetis business objectives, veterinary drug development projects, regulatory change management and/or routine registration maintenance. Other: - Develop regulatory CMC filing strategies for global pharmaceutical dosage forms. - Support CMC activities for new product development teams and post-approval manufacturing changes or site transfers. - Prepare responses to global Health Authority queries including FDA/CVM. - Maintain knowledge and awareness of emerging global biopharma and pharmaceutical CMC regulations and assist in the development of Zoetis regulatory positions and strategies. - Develop strong working relationships with both Zoetis manufacturing sites and contract manufacturing interfaces for assigned portfolio. - Provide regulatory support and serve as a technical liaison on Development teams in their efforts to deliver a quality CMC technical section that will meet global requirements for registration, approval and launch of a new product. - Develop a knowledge of CMC regulatory science. - Work with VMRD Pharmaceutical Sciences to...