Title:
Manager, Global Diagnostics Regulatory Affairs
Location:
Kalamazoo
Reports To:
Director, Global Regulatory Affairs and Pharmacovigilance, VMRA
Zoetis:
Zoetis is a global animal health company with over 60 years of experience. We deliver quality medicines and vaccines, complemented by diagnostics products and genetics tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals. Zoetis develops innovative animal health solutions to detect, predict, prevent and treat diseases, by relying on world-class talent, teamwork and pioneering science.
R&D - Veterinary Medicine Regulatory Affairs (VMRA):
The Veterinary Medicine Regulatory Affairs department provides regulatory expertise, support and guidance to the Zoetis research and development (R&D) project teams and to our manufacturing facilities in support of on-market product. Zoetis VMRA provides regulatory strategy and advises on the required data and documentation needed to meet regulatory and legislative requirements to ensure approval and maintenance of existing diagnostic products, vaccines and medicines.
Global Diagnostics Regulatory Affairs Manager:
The position of Global Diagnostics Regulatory Affairs will support global regulatory diagnostic aspects of an assigned product portfolio associated with Zoetis business objectives, veterinary and human diagnostic development projects, regulatory change management and/or routine registration maintenance , Regulatory scope will include that applicable to consumables for both infectious and non-infectious disease as well as for instruments. Responsibilities include communication, owning deliverables and embracing priorities that align with the needs of Zoetis stakeholders and partner groups.
Your Responsibilities:
- Provide regulatory strategy and support as member of multidisciplinary, Diagnostic Product Development Teams.
- Communicate early regulatory input into early phase Discovery projects.
- Provide risk assessments and due diligence when applicable.
- Author globally compliant diagnostic regulatory dossiers
- Offer guidance and documentation to In Country Regulatory Affairs Managers (icRAMS) in non-US markets in support of their regulatory registrations.
- Supply regulatory support and advice for post-market 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 applicable
- Liaise with icRAMs to assure Diagnostic products are properly entered and maintained in Zoetis Systems.
Experience and Background:
An appropriate degree in animal sciences or a related discipline.
- 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.).
Alternatively, demonstrated relevant experience gained with Regulatory and/or Pharmacovigilance Databases, preferably, or diagnostic product development in an Animal Health environment.
Ideally has knowledge of veterinary medicines / vaccines across multiple geographies and regulatory jurisdictions.
Technical Skills Requirements:
- Understanding of the veterinary or human diagnostics development process and regulatory requirements desirable.
- Knowledge in the production and testing of veterinary diagnostic 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 VMRA as the need arises.
Our offer:
- A rewarding career through a challenging role in a multicultural environment that supports continuous learning and development. The successful candidate will have ownership for key objectives and be an integral part of a successful team that delivers products to detect and prevent disease in animals.
Application:
Please apply online using an English resume and motivation letter.
Full time
Regular
Colleague
