Demo

Director, Regulatory Affairs

Zoetis, Inc
Kalamazoo, MI Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 5/29/2025

Role

As Director of US Biologics Regulatory Affairs, this individual will be located at our Kalamazoo location and responsible for Registration of Veterinary Biologicals in North America, coordinate regulatory support of licensed products, and regulatory support for APAC, CLAR and EU Biological RA groups. The position will address veterinary biological product registration needs for the United States and will be responsible for ensuring biological products are in compliance with USDA CVB regulatory requirements.

Primary Responsibilities include (but not limited to) the following :

  • Leadership role in registration of veterinary biologicals in North America and support for the APAC, CLAR and European markets.
  • Ensure appropriate regulatory support for multidisciplinary Project Teams responsible for developing veterinary biological products, develop the regulatory strategy for the team, and be responsible for coordinating all US regulatory submissions for that project with minimum supervision from the Senior Director.
  • Leadership role in regulatory support for Business Development.
  • Assist Senior Director with representation on biological trade organizations.
  • Coordinate regulatory support of licensed products.
  • Liaise with New Product Marketing to develop label claims and product supporting materials.
  • Liaise closely with EU and CLAR / APAC regulatory staff to facilitate global registration where appropriate.
  • Serve as an alternate Liaison with USDA.
  • Provide regulatory support and advice regarding GMS initiatives and market enhancements.

Experience and background :

  • PhD or DVM desired
  • A minimum of 10 years experience with veterinary biological products preferably in regulatory affairs or a related area.
  • Strong verbal and written communication skills, and a demonstrated ability to lead teams and work in a team environment.
  • Understanding of the veterinary biological development process and USDA regulatory requirements
  • Knowledge in the production and testing of veterinary biological products desirable.
  • Technical Skills Requirements :

    At a minimum :

  • Possess detailed understanding of what it takes to be an effective support to colleagues / teams in a multicultural, dynamic, and constantly changing environment.
  • Strong People leadership skills.
  • Exhibit effective communication skills in English (both written and oral) with colleagues at all levels of the organization and external regulatory agencies.
  • Consistently model behaviors of accountability and ownership through approachability, excellent interpersonal, communication, negotiation, and problem-solving skills.
  • Ability to work independently, while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once.
  • Highly effective team player and creative problem solver.
  • Superior negotiation skills.
  • 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.

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Director, Regulatory Affairs?

    Sign up to receive alerts about other jobs on the Director, Regulatory Affairs career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $212,419 - $307,933
    Income Estimation: 
    $308,977 - $498,049
    Income Estimation: 
    $263,669 - $375,263
    Income Estimation: 
    $212,419 - $307,933
    Income Estimation: 
    $308,977 - $498,049
    Income Estimation: 
    $263,669 - $375,263
    Income Estimation: 
    $263,669 - $375,263
    Income Estimation: 
    $308,977 - $498,049
    Income Estimation: 
    $78,084 - $104,270
    Income Estimation: 
    $95,800 - $126,196
    Income Estimation: 
    $97,803 - $128,184
    Income Estimation: 
    $95,508 - $129,349
    Income Estimation: 
    $176,359 - $246,541
    Income Estimation: 
    $242,066 - $328,520
    Income Estimation: 
    $212,419 - $307,933
    Income Estimation: 
    $190,069 - $273,730
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Zoetis, Inc

    Zoetis, Inc
    Hired Organization Address Lincoln, NE Full Time
    Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. Looking for your chance to work for t...
    Zoetis, Inc
    Hired Organization Address Lincoln, NE Full Time
    States considered : Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis in Linc...
    Zoetis, Inc
    Hired Organization Address Durham, KS Full Time
    Position Summary : We are seeking a proactive and adaptable Scientist to join our Bioscience Process and Validation team...
    Zoetis, Inc
    Hired Organization Address Charles, IA Full Time
    Role Description Zoetis seeks an experienced, proven Finance leader to join the management team at their manufacturing s...

    Not the job you're looking for? Here are some other Director, Regulatory Affairs jobs in the Kalamazoo, MI area that may be a better fit.

    Regulatory Affairs Manager

    CEDENT, Schoolcraft, MI

    AI Assistant is available now!

    Feel free to start your new journey!