Sr Associate / Manager, US Pharmaceutical Regulatory Affairs

Job Listing No: 9740000

Sr Associate / Manager, US Pharmaceutical Regulatory Affairs

Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.Our name, Zoetis (z-EH-tis), has its root in zo, familiar in words such as zoo and zoology and derived from zoetic, meaning “pertaining to life.” It signals our company”s dedication to supporting the veterinarians and livestock producers everywhere who raise and care for the farm and companion animals on which we all depend on.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. 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 site, or (2) via email to/from addresses using only the Zoetis domain of “”. 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.POSITION RESPONSIBILITIES: 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.

Apply for this job.

Similar Jobs For "Sr Associate / Manager, US Pharmaceutical Regulatory Affairs"

 Jobs by Indeed job search

Associate Portfolio Manager

Company: City National Bank
Location: Beverly Hills, CA
Portfolio Managers (SPM) in the development of short-and long-term investment strategies and approaches to achieve investment goals for clients. To apply for this job vacancy in City National Bank you must be qualified and you should prepare the required documents, click on the job link for more details.
Posted 3 hours ago

Associate Manager

Company: CT Gardens LLC
Location: North Haven, CT 06473
FT Associate Manager needed for myAgway; Your local lawn, garden, nursery, and pet retail store. Successful candidates must have a minimum of two years retail… To apply for this job vacancy in CT Gardens LLC you must be qualified and you should prepare the required documents, click on the job link for more details.
Posted 2 hours ago

Product Specialist, Bomar

Company: Dymax Corporation
Location: Connecticut
Minimum Associates Degree in combination with a minimum of 3 years of relevant experience; Works with Marcomm and Business Development Manager to develop… To apply for this job vacancy in Dymax Corporation you must be qualified and you should prepare the required documents, click on the job link for more details.
Posted 4 hours ago

Project Management Assistant

Company: IBM
Location: West Virginia
Project Management Assistants function as an adjunct to the manager, you would be completing tasks as assigned such as: To think along with clients and sell. To apply for this job vacancy in IBM you must be qualified and you should prepare the required documents, click on the job link for more details.
Posted 2 hours ago

Associate Facilities Manager- Biopharmaceutical Facility

Company: CBRE
Location: Rockville, MD 20850
Associates degree or Bachelor’s degree preferred with focus on Engineering preferred. The purpose of this position is to manage multiple functions of building… To apply for this job vacancy in CBRE you must be qualified and you should prepare the required documents, click on the job link for more details.
Posted 1 hour ago

Note: This job listing with titled "Sr Associate / Manager, US Pharmaceutical Regulatory Affairs" was indexed from different job portals. This job might be expired or closed for accepting CV's so we suggest to browse it from the new jobs menu of this site. Our website is an open community website for assisting job seeker so if you found some broken links or error in our site don't hesitate to contact us to fix the issue. Thank you for using our free services.