Diagnostics Regulatory Affairs Manager
Company: Zoetis, Inc.
Posted on: January 15, 2020
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.
*Develop regulatory strategies as a project team member on
multidisciplinary, Diagnostic Product Development Teams.
*Communicate regulatory input into early phase Discovery
*Provide risk assessments and conduct due diligence exercises as
*Offer guidance and documentation to In Country Regulatory Affairs
Managers (icRAMS) in non-US markets in support of their regulatory
*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.
*BA/BS/MS in biology, animal science, pharmacy or other related
*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
*Strong verbal and written communication skills, and a demonstrated
ability to work in a team environment.
-Ability to effectively support colleagues / teams in a
multicultural, dynamic and constantly changing learning
-High level of competency using Microsoft Office suite with
demonstrated high level competence of working in Microsoft Word and
-Must be able to effectively communicate in English with colleagues
at all levels of the organization and external regulatory
-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.
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@example.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..
Keywords: Zoetis, Inc., Kalamazoo , Diagnostics Regulatory Affairs Manager, Executive , Kalamazoo, Michigan
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