States considered: All

Role Description

Zoetis Global Regulatory Affairs is looking for individuals interested in working for a global company where you can work across functions supporting international and team initiatives. Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

We are proud to be named one of Forbes Best Midsize Employers as well as 100 Best Company’s and Top Company for Working Parents by Seramount, and Management Top 250 List by WSJ. Learn more about our award-winning organization by visiting zoetis.com.

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

We are currently seeking a Global Biologics and Diagnostics Labeling Manager to be based hybrid at headquarters in Kalamazoo, Michigan or remotely anywhere in the US.

The position of Global Biologics and Diagnostics Labeling Manager is a leadership position for management of people and labeling projects, including strategic and planned label changes of an assigned product portfolio for animal health and human health diagnostic and animal health biologic products. This position will lead a small global team supporting USDA artwork strategy, submission, and globally shared label strategy across the product lifecycle. Responsibility to be a label lead in cross functional teams and drive alignment for labeling projects including manufacturing, engineering, regulatory and supply chain, among others, to achieve the business and compliance objectives. This role requires the ability to leverage technical knowledge of systems, processes, and regulations as well as have a clear understanding of end-to-end process to drive global labeling solutions and strategy. Ensures assurance of compliance to content and market requirements for new product launches, USDA label submissions, instrument compliance updates and other core labeling programs. Responsibilities include communication, owning deliverables and embracing priorities that align with the needs of Zoetis stakeholders and partner groups.

Job Responsibilities:

• Global product leadership for strategic planning of label projects. Manages workload, timelines, and resources for label projects and empowers global team. Informs team early about possible issues. Plans and prepares for possible issues and formulates a mitigation plan.
• Responsible for the performance management of labeling team.
• Educate and train others on Global Labeling Systems, Processes, and Procedures as applicable.
• Liaise with business partners to assure biologics and diagnostic label requirements are incorporated into global labels and maintained in Zoetis Systems.
• Proven successful project management leadership skills.
• Understanding of USDA regulatory labeling standards and keeping the labeling team informed of new labeling requirements.
• Lead shared label strategy development and maintenance over the product life cycle.
• Works with Artwork Center, Product Management, Regulatory, and Instrument Compliance to resolve quality issues regarding labelling, and develops internal and external processes geared toward minimizing and eliminating labelling issues.
• Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines and company.
• Educate, train, and guide stakeholders to provide accurate information in support of successful labeling changes and new label development.

Experience and Background:

• Minimum 5-7 years’ experience in regulatory affairs with human health/animal health biologics and/or in-vitro diagnostics experience.
• BS degree in science such as Biology, Chemistry or related science is required. Advanced degree desirable.
• Knowledge of labeling regulations across multiple geographies and regulatory jurisdictions preferred.
• Comprehensive knowledge of US FDA / USDA Regulations.

Technical Skills Requirements:

• Strong project management skills including stakeholder management.
• Strong interpersonal skills with the ability to influence others in a positive and effective manner.
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment.
• Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies to ensure that the expectations of all submissions to external agencies are met.
• Knowledge in the production and testing of biologic/IVD products desirable.
• Strong verbal and written communication and negotiation skills, and a demonstrated ability to work in a team environment.
• Detailed understanding of effective administrative support to colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
• High level of competency using Microsoft Office suite – with demonstrated high level competence of working in Microsoft Word and Excel.
• Must be able to effectively communicate in English 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. 
• Able to demonstrate evidence of being a highly effective team player, be a problem solver with an ability to take ownership for issues and have the ability to come up with creative solutions and implement them successfully.

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: $91,000 - $131,000

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: $103,000 - $148,000

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

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.

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 [email protected] 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.