Regulatory Affairs Specialist

Regulatory Affairs Specialist

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 to 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).
• Utilizing technical regulatory skills to influence USDA on issues.
• Interacting 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.
• Communicating the regulatory position to internal stakeholders.

• Prepare/write clear arguments and explanations in order 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.
• Identifies and communicates potential risks and mitigations associated with regulatory strategies and stakeholders.
• Oversee the compliance of the analytical and clinical development plans with regulatory requirements of the USDA and their alignment with the specifications of each project.
• Participate in project team meetings by assessing the regulatory requirements to achieve product approvals for post‑licensure changes. Staying current with all regulatory related tasks and providing progress updates as needed.
• Reviewing and reporting issues that should be addressed before documents are submitted to the USDA. Proposing corrective actions to minimize risk at submission.
• Review and advise regarding the regulatory documentation before submission. Carries the responsibility that data is in full compliance before submission.
• Ensure that complete up‑to‑date records are maintained for compliance and guarantee of product integrity.
• Ensuring the consistency and completeness of the technical regulatory documents for all submissions.
• Review Document Changes, Non‑Conformance Reports and Corrective Action Preventative Action documents for current products and procedures to ensure…