Manager/Associate Director, US Regulatory Affairs job opportunity at Zoetis.

Home Jobs In United States Of America Tag: US Regulatory Affairs Manager/Associate Director, US Regulatory Affairs position at Zoetis


DateMore Than 30 Days Ago bot
Zoetis Manager/Associate Director, US Regulatory Affairs
Experience: 8-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

US Regulatory Affairs

Copy Link Report
degreeAssociate
loacation Kalamazoo - Downtown Portage Street, United States Of America
loacation Kalamazoo - Do..........United States Of America

The successful candidate will be the regulatory strategy lead for US FDA regulated products, providing guidance and technical support for new product registrations and supplemental claims as a part of global veterinary pharmaceutical and biopharmaceutical development project teams. The person will be responsible for ensuring that these products are developed, approved, and maintained in full compliance with Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) requirements. The candidate will lead strategy and interactions with FDA-CVM to enable product approval. To accomplish these responsibilities, the candidate will work closely with colleagues across Veterinary Medicine Research and Development (VMRD) and Global Portfolio Marketing (GPM) to facilitate product development, approval and maintenance consistent with the company operating plans and the project portfolio. The candidate will also liaise with EU and CALAR regulatory colleagues to support global registration activities, where appropriate. Key responsibilities: Serve as regulatory subject matter expert and member on multidisciplinary project teams (food and companion animal) responsible for developing veterinary pharmaceutical and biopharmaceutical products. Develop and implement the regulatory strategy for assigned teams, accepting the responsibility of all US FDA regulatory submissions and interactions for that project. Serve as liaison with Global Research and other VMRD colleagues to help provide early regulatory input into early phase projects. Liaise with GPM and Therapeutic Area Leads to establish suitable product profiles, regulatory jurisdiction, label claims, product support materials, as well as project progression documentation. Assemble original and supplemental applications and coordinate subsequent responses to US Regulatory Authority questions. Liaise directly with FDA-CVM as needed to achieve objectives. Liaise with EU and CALAR regulatory staff to facilitate global registration activities, where appropriate. Provide regulatory support and guidance regarding Global Manufacturing initiatives and Commercial market enhancements. Serve on industry working groups to engage with FDA-CVM on current and proposed policy and regulation. Minimum Skills, Education, Experience and Attributes: Master’s or DVM and/or PhD degree, in a relevant scientific discipline (animal science, veterinary medicine, immunology, toxicology/pharmacology or similar). 8+ years’ experience between US regulatory affairs and a related animal health discipline, involving interaction with the FDA-CVM. Demonstrated abilities in areas of regulatory interpretation and procedures including phased, original, and supplemental applications. Understanding of the veterinary medicinal product development process, including early and late-stage development activities. Knowledge of safety/efficacy and dossier assembly for FDA-CVM. Knowledge in the production and testing of biopharmaceutical veterinary medicinal products is desirable.  Excellent oral and written communication and negotiation skills and a demonstrated ability to multi-task and work in a global team environment (including virtual). Fluency in English required.. Excellent functional knowledge of Microsoft platforms and associated Office suite programs. Well-developed verbal and written communications skills and organizational strategies. Full time Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. 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 zoetiscolleagueservices@zoetis.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.

Other Ai Matches

remote-jobserver Remote
Platinum Veterinary Advisor Applicants are expected to have a solid experience in handling Job related tasks
Aseptic Technician I Applicants are expected to have a solid experience in handling Job related tasks
Lead Pharma Packaging Technician 1st Shift 6:00am – 2:30pm Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Field Service Specialist Applicants are expected to have a solid experience in handling Job related tasks
Lab Tech 1 – Chemistry Applicants are expected to have a solid experience in handling Job related tasks
Director, Global Strategy Applicants are expected to have a solid experience in handling Global Strategy related tasks
Senior Scientist - Virology/Molecular Biology Applicants are expected to have a solid experience in handling Job related tasks
Operational Excellence and Training Intern Applicants are expected to have a solid experience in handling Job related tasks
Manager, US Regulatory Affairs- Advertising & Promotion Applicants are expected to have a solid experience in handling US Regulatory Affairs- Advertising & Promotion related tasks
Aseptic Technician I Applicants are expected to have a solid experience in handling Job related tasks
Formulation Specialist – Aseptic (2nd Shift) Applicants are expected to have a solid experience in handling Job related tasks
Learning & Development Media Specialist Applicants are expected to have a solid experience in handling Job related tasks
Formulation Specialist I (3rd Shift) Applicants are expected to have a solid experience in handling Job related tasks
Master Seed Facility Scientist Applicants are expected to have a solid experience in handling Job related tasks
Scientist/Senior Scientist Applicants are expected to have a solid experience in handling Job related tasks
Scientist / Sr. Scientist – Biopharmaceutical Pilot Registration Lab Applicants are expected to have a solid experience in handling Job related tasks
Sterilization Technician – B2 Tank Operations 2nd Shift 2:00pm – 10:30pm Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Technical Services Veterinarian Equine Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Senior Product Manager, Marketing Cloud & Automation Applicants are expected to have a solid experience in handling Marketing Cloud & Automation related tasks
Packaging Specialist I (2nd shift) Applicants are expected to have a solid experience in handling Job related tasks
Aseptic Technician I Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Area Business Manager Applicants are expected to have a solid experience in handling Job related tasks
Information Technology Intern – Veterinary Medicine R&D & Commercial Genetics Applicants are expected to have a solid experience in handling Job related tasks