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.
- 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.