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Manager, Global Diagnostics Regulatory Affairs

Zoetis

Last Updated: 3/07/21

Job Description

Job Summary:

The position of Global Diagnostics Regulatory Affairs Manager will support global human health regulatory aspects of an assigned product portfolio associated with Zoetis business objectives, regulatory change management and/or routine registration maintenance. Regulatory scope will include applicable consumables as well as for instruments. Responsibilities include communication, owning deliverables and embracing priorities that align with the needs of Zoetis stakeholders and partner groups.

Job Responsibilities:

  • Provide regulatory strategy for Class I and II IVDs, export/import regulations and labeling requirements.
  • Provide risk assessments when applicable.
  • Author globally compliant diagnostic regulatory dossiers.
  • Represent Regulatory Affairs in support of site quality management system initiatives.
  • Supply regulatory support and advice for post-market initiatives and market enhancements.
  • Provide regulatory guidance to the diagnostic label team.
  • Build and maintain technical files.
  • Educate and train others on Global Regulatory Systems, Processes, and Procedures as applicable.
  • Liaise with business partners to assure Diagnostic products are properly entered and maintained in Zoetis Systems.

Experience and Background:

  • Minimum 3-5 years’ experience in regulatory affairs with human in-vitro diagnostics experience.
  • BS degree in science such as Biology, Chemistry or related science is required.
  • An appropriate degree/certification in regulatory affairs, or a related discipline is preferred.
  • Demonstrated relevant experience gained with Regulatory Affairs, preferably with diagnostic product development in a Human Health environment.
  • Knowledge of human health device regulations across multiple geographies and regulatory jurisdictions preferred.
  • Comprehensive knowledge of US FDA Regulations (21 CFR 800 series and applicable regulations).
  • Experience in preparation of regulatory submissions.
  • Experience in interpretation of regulations, guidelines, and policies.

Technical Skills Requirements:

  • Knowledge in the production and testing of IVDs 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.
  • Attention to detail is critical to ensure that the expectations of all submissions to external agencies are met.
  • 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.
  • He/she will be able to influence without authority and support colleagues outside of Regulatory Affairs as the need arises.

Full time

Regular

Colleague

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 [Register to View] 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 [Register to View] 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.



Company Details


Zoetis

Parsippany, New Jersey, United States

Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.