(Archived) Diagnostics Regulatory Affairs Manager

Zoetis is seeking a team player to fill the position of Regulatory Affairs Manager. The position holder will secure veterinary and human diagnostic product marketing authorizations (including instruments, consumables and lateral flow diagnostics) and permits for global markets. The ideal candidate will collaborate with cross-functional stakeholders to ensure compliance with regulatory requirements through effective communication, owning deliverables and embracing priorities.

Responsibilities include:

•Develop regulatory strategies as a project team member on multidisciplinary, Diagnostic Product Development Teams.

•Communicate regulatory input into early phase Discovery projects.

•Provide risk assessments and conduct due diligence exercises as applicable.

•Offer guidance and documentation to In Country Regulatory Affairs Managers (icRAMS) in non-US markets in support of their regulatory efforts.

•Liaise closely with US regulatory staff to facilitate global registrations where appropriate.

•Supply regulatory support and advice for Global Manufacturing and Supply initiatives and market enhancements.

•Provide regulatory guidance to the diagnostic label team in support of new products, line extensions.

•Educate and train others on Global Regulatory Systems, Processes, and Procedures as necessary.

•Liaise with icRAMs to assure Diagnostic products are properly entered and maintained into Zoetis Systems (Trackwise: ETS-Registration Tracking and ETS-Submission Tracking; Veeva Vault – archiving) processes are upheld.

Requirements:

•BA/BS/MS in biology, animal science, pharmacy or other related science.

•PhD or DVM desirable.

•A combination of relevant experiences may be considered (for example, 3-5 years’ experience with diagnostics products preferably in regulatory affairs or a related area.).

•Understanding of the veterinary and human diagnostics development process and regulatory requirements.

•Knowledge in the production and testing of diagnostic products preferred.

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

Desirable Skills:

-Ability to effectively support 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 with the ability to come up with creative solutions and implement them successful.

-He/she will be able to influence without authority and support colleagues outside of Regulatory Affairs as the need arises.