Manager I - US Biologics Regulatory Affairs

States considered: Michigan

Role Description

The position will address veterinary biological product registration needs for the United States. Candidate will be responsible for ensuring that biological, including biopharmaceutical, products are developed, registered, and maintained in compliance with USDA Center for Veterinary Biologics regulatory requirements. Candidate will liaise closely with other US biologics regulatory staff to facilitate US registrations consistent with the company portfolio plan. Candidate will also connect with international regulatory staff to facilitate global registration where appropriate. Candidate will represent regulatory affairs on project teams with the responsibility to align with partner groups and organizations to drive product registrations consistent with approved product profiles.

Position Responsibilities

1. Serve as member on multidisciplinary project teams responsible for developing veterinary biological and biopharmaceutical products, develop the regulatory strategy for the team, and be responsible for all US regulatory submissions for that project with high level of autonomy.

2. Serve as an advisor in early lead seeking and research phase projects to provide timely regulatory input and direction.

3. Liaise with Global Commercial Development and Global Biologics teams to develop and negotiate label claims and product supporting materials.

4. Liaise closely in the regions to facilitate global registration where appropriate.

5. Provide regulatory support and advice regarding Global Manufacturing and Supply initiatives and market enhancements.

6. Provide regulatory support of biological product labeling, advertisement, and promotional materials.

7. Provide regulatory support to internal regulatory group processes and systems when needed for unlicensed and licensed products.

Education and Experience

* MS in biology, animal science or other related science.

* PhD or DVM desirable.

* A minimum of 5 years' experience with veterinary biological products, preferably in regulatory affairs or a related area.

* Veterinary clinical experience will also be considered.

* Technical Skills Requirements

* Strong verbal and written communication skills, and a demonstrated ability to work in a team environment.

* Understanding of the veterinary biological development process and USDA regulatory requirements desirable.

* Knowledge in the production and testing of veterinary biological products desirable.

* Being comfortable with standard software (Excel, etc.) and communication technologies.

Position will be on site, Kalamazoo MI, or remote.

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to
be located in (Colorado). Base pay may vary based on location and other factors.

Base Pay Range: $86,000 - $124,000

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and
other factors.

Base Pay Range: $98,000 - $141,000

[This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.]

We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and

retirement savings benefits along with paid holidays, vacation and disability insurance.

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.