(Archived) Manager/Associate Director, US Regulatory Affairs

Job Scope:

The Zoetis Veterinary Medicine Research and Development (VMRD) organization is focused on continuously innovating to develop animal health solutions that meet the global needs of those who raise and care for animals. The company is currently seeking a qualified individual to join its US Regulatory Affairs team. The position entails being a principal company liaison between the assigned project team(s) and the Food and Drug Administration/Center for Veterinary Medicine (FDA-CVM) for the approval of new animal drug products, both pharmaceutical and biopharmaceutical.

Responsibilities:

To build quality enduring relationships with personnel at FDA-CVM based on integrity, trust and respect, and high quality science. To help to ensure optimal regulatory interactions with the FDA-CVM in relation to the assigned project(s) and ensure that questions, project updates and or requests are addressed in a timely manner.

To represent the Zoetis US Regulatory Affairs team on cross-functional pharmaceutical and biopharmaceutical project team(s), providing strategic, proactive and timely regulatory and technical expertise throughout the planning and execution of the project(s) or other related tasks.

To be jointly accountable for aligning the regulatory strategy with the business needs and delivering on project goals.

To work with project team members to develop content and structure of high quality regulatory submissions that fulfill regulatory requirements and the expectations of regulatory agency personnel.

To be accountable for timely submissions and subsequent approvals that ensure overall project objectives are met.

Minimum Skills, Education, Experience and Attributes:

Bachelor’s or Master’s degree, in a relevant scientific discipline (animal science, veterinary medicine, immunology, toxicology/pharmacology or similar). DVM and/or PhD are highly desirable. At least 5 years’ experience in the animal health industry, preferably in regulatory affairs, is required. Several years of practical experience in an animal science discipline or in the practice of veterinary medicine would also be highly desirable. Experience working in a team environment (including virtual) is also highly desirable.

Technical Skill Requirements:

Experience in developing regulatory submissions and interacting with regulatory agency personnel is required. Technical and regulatory knowledge of animal health product development, especially food animal products, is highly desirable. Excellent oral and written communication and negotiation skills are required as is a high attention to detail. Need to be fluent in English. Good functional knowledge of Microsoft platforms and associated Office suite programs.