Director, Regulatory Affairs

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.

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.