Manager/Associate Director, US Pharmaceutical Regulatory Affairs
Published: 5 January 2018
Location: Kalamazoo, MI, United States.
To Apply: Search on JR00001750 via Careers United States at www.zoetis.com
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 at its VMRD headquarters in Kalamazoo, MI. 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.
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 Pharmaceutical group on cross-functional pharmaceutical and biopharmaceutical project team(s), primarily food animal species, 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. Several years of practical experience in an animal science discipline or in the practice of veterinary medicine would also be highly desirable, as would regulatory and/or product development experience in the animal health pharmaceutical industry. Experience working in a team environment is also highly desirable.
Technical Skill Requirements:
Technical and regulatory knowledge of animal health product development, especially food animal products, is desirable. Experience in developing regulatory submissions and interacting with regulatory agency personnel is also desirable. Excellent oral and written communication and negotiation skills are required as is a high attention to detail. Need to be fluent in English. Functional knowledge of Microsoft platforms and associated Office suite programs.
Search on JR00001750 via Careers United States at www.zoetis.com
Zoetis offers a competitive salary and benefits package, with relocation assistance if required.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact.
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