Senior Associate/Manager, Diagnostic Regulatory Affairs

1 month ago

Kalamazoo, United States Zoetis Full time
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 the top companies for sustained commitment to advancing Diversity, Equity and Inclusion (DE&I) by Fair360 as well as a Top Company for Working Parents by Seramount, and 2-year honoree for World's Most Ethical Companies by Ethisphere. 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 Senior Associate/Manager Diagnostics Regulatory Affairs lead to be based hybrid at headquarters in Kalamazoo, Michigan or remotely anywhere in the US.

The position of Senior Associate/Manager Diagnostics Regulatory Affairs lead will be an individual contributor as part of Zoetis' Global Diagnostics Regulatory Affairs and serve as the regulatory strategist on cross functional teams. This position will have main responsibilities of addressing global regulatory affairs registration, renewal and compliance activities for veterinary diagnostic product registration and compliance needs in U.S. and/or non-US countries, which would include the international regions. Responsibilities will include addressing global regulatory affairs registration, renewal and compliance activities for veterinary diagnostics products.

This position requires the ability to (1) organize information on regulatory requirements, (2) understand scientific concepts and (3) apply knowledge towards a specialized regulatory function in support of pre and post approval diagnostic products. Provide support to regional market regulatory managers on registration strategies and timelines. 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 registration strategy. Ensures assurance of compliance to content and market requirements for new product launches, renewals, variations, and other core life cycle programs. Responsibilities include communication, owning deliverables and embracing priorities that align with the needs of Zoetis stakeholders and partner groups.

Job Responsibilities:
  • Contributes at the functional level may represent their function on several multi-disciplinary Project Teams responsible for providing regulatory input, strategy, and technical guidance, on US and/or global regulatory requirements to influence the team /group to deliver on objectives.
  • Provide risk assessments and review study protocol/reports for projects when applicable.
  • Liaise closely with regulatory team members to support resource needs and to facilitate global registration where appropriate.
  • Supply regulatory support and advice regarding GMS initiatives and market enhancements.
  • Provide input to label copy in support of new products, line extensions.
  • Provide regulatory guidance and documentation to in-country regulatory managers in non-US markets for notifiable change dossiers.
  • Provide regulatory input and appropriate follow-up for inspections, audits, and recall actions.
  • Lead sub-teams within their function to analyze processes, identify problems, and develop effective solutions/strategies.
  • Author regulatory dossiers to support global expansion. 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 global submissions.
Experience and Background:
  • Minimum 2-5 years' experience in regulatory affairs with 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 diagnostic regulations across multiple geographies and regulatory jurisdictions preferred.
  • Knowledge of US FDA / USDA Regulations desirable.
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.


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.

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