Sr Associate / Manager, US Pharmaceutical Regulatory Affairs
Company: Zoetis, Inc.
Posted on: February 12, 2019
Under the direction of management, to represent the US Regulatory Affairs Pharmaceutical group on cross-functional pharmaceutical and/or biopharmaceutical project team(s), primarily companion animal species, providing strategic, proactive and timely regulatory expertise throughout the planning and execution of the project(s) or other related tasks.
To serve as a regulatory resource to other functional lines or individuals that may or may not be directly involved with ongoing projects or existing teams.
To be co-accountable for delivering the project goals and aligning the regulatory strategy with the business needs.
To author or co-author high quality regulatory component documents used in the production of a submission.
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.
To help to ensure optimal regulatory interactions with the Food and Drug Administration (FDA)/Center for Veterinary Medicine (CVM) in relation to the assigned project(s) and ensure that questions, project updates and or requests are addressed in a timely manner.
EDUCATION AND EXPERIENCE:
Bachelor s or Master s degree, in a relevant scientific discipline (animal science, veterinary medicine, immunology, toxicology/pharmacology or similar). DVM and/or PhD is highly desirable.
Minimum of three years experience in the animal health (or possibly human health) pharmaceutical or biopharmaceutical product development industry.
Regulatory affairs knowledge (especially regarding registration of animal health products with FDA-CVM), experience in developing regulatory submissions, and interacting with regulatory agency personnel are highly desirable. Experience in dealing with development and/or registration of biopharmaceutical products with FDA-CVM would be a bonus.
TECHNICAL SKILL REQUIREMENTS:
Excellent oral and written communication and negotiation skills. Very organized with strong attention to detail. Experience working in a matrixed global and multi-site environment is desirable. Functional knowledge of Microsoft platforms and associated Office suite programs that may include but are not limited to Outlook, Word, Excel and PowerPoint. Experience with electronic submissions to regulatory authorities and/or project management experience would be a bonus.
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. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at email@example.com to request an accommodation. 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. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of @zoetis.com . In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Keywords: Zoetis, Inc., Kalamazoo , Sr Associate / Manager, US Pharmaceutical Regulatory Affairs, Healthcare , Kalamazoo, Michigan
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