Regulatory Affairs Specialist

The success of a company depends on the passionate people we partner with. Together, let's share our talents. As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing, producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet. We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach. As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Health is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants.

To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Location:

Lenexa, KS

The position is responsible for life cycle management of vaccines for Ceva Animal Health. The Specialist will work with GMSQ to provide regulatory guidance and prepare submissions to the USDA to support compliance and maintain existing licenses. Other responsibilities would include, but are not limited to, reviewing and providing regulatory guidance for protocols and reports prior to submission to USDA, providing regulatory input for LCM projects, and organizing meetings for completion of regulatory documents related to specific projects.

This position will stay up to date on new regulations to ensure license maintenance, compliance and product life cycle management guidelines are maintained. The ideal candidate monitors changes to regulations to determine the impact on existing licenses.

• Support RA manager to help drive projects to completion, including assignment of regulatory tasks and deadlines as needed.
• Represent Ceva Animal Health in external activities including trade associations and professional organizations.
• Oversee submissions and responses to and from the USDA. Interpret and prepare/write clear arguments and explanations to answer the questions and comments needed from the USDA for compliance submissions.
• Keep abreast of new USDA guidelines and memoranda.
• Provide up-to-date reports and timelines of projects to keep all departments informed of developments.
• Update any applicable computer tracking systems (such as a document tracker or planned submissions database).
• Keep track of all versions of post-licensure documents needed for submission to USDA.
• Build effective working relationships with key business partners, regulators, customers, suppliers and colleagues.

• Maintains awareness of regulatory practices, procedures, and changes, as appropriate by project. Assesses impact of the changing regulatory environment on the project, and advises regulatory colleagues and project team members, as appropriate, regarding potential course(s) of action.
• Proactively works on the implementation of compliance with current regulations (e.g., new memoranda from USDA).
• Utilizes technical regulatory skills to influence USDA on issues.
• Interacts with USDA in a persuasive manner for their understanding and acceptance of proposed regulatory approaches.
• Taking initiative to learn scientific innovation using multiple resources to expand skills and apply them.
• Communicates the regulatory position to internal stakeholders.

• Prepare/write clear arguments and explanations to answer the questions and comments needed from the USDA for existing product licenses.
• Responsible for annual outline reviews, preparation and submission of revised outlines.
• Responsible for annual facility document reviews, preparation and submission of revised facility documents.
• Identify and communicate potential risks and mitigations associated with regulatory…