Regulatory Affairs Manager - Verona, WI

The Regulatory Affairs Manager is responsible for assisting in the day-to-day operations for regulatory compliance at the Verona, WI, campus. The role will be responsible for the regulatory submissions associated with autogenous and prescription vaccines. The ideal candidate will understand and translate regulatory and business requirements to optimize timely submission approvals, and product compliance. This position also will ensure all government report systems and documentation comply with regulatory requirements for veterinary biological products. The Regulatory Affairs Manager will work in a team environment to provide regulatory support to all departments. Serve as the central contact internally and externally for autogenous and prescription products, ensuring product regulatory compliance through the lifecycle of these products. This role builds strong partnerships and drives proactive cross-functional engagement with stakeholders within and outside the company.

The role will also assist the Quality Assurance Manager with USDA regulatory compliance activities as needed, such as during Health Authority Inspections, and responses for these activities.

Leadership:

* Serve as USDA contact and liaison for the Verona campus

* Oversee submissions and responses to and from the USDA regarding the vaccines produced in the Verona campus.

* Ensure you remain up to date and are well-informed of new USDA guidelines and memoranda.

* Build effective working relationships with key business partners, regulators, customers, suppliers and colleagues.

* Maintain oversight of all regulatory related tasks and provide progress updates as needed.

* Assist the QA Manager with investigations and compliance requests to USDA.

Regulatory Intelligence:

* Maintains awareness of regulatory practices, procedures, and changes, as appropriate by project.

* Assess impact of the changing regulatory environment on the project, and advises regulatory colleagues and project team members, as appropriate of potential course(s) of action.

* Proactively works on the implementation of compliance with current regulations (new memoranda from USDA).

* Collaborate with the USDA to clarify and provide understanding of the proposed regulatory approaches.

* Take initiative to learn scientific innovation, using multiple resources to expand skill set and apply the skills.

* Communicate the regulatory position to internal stakeholders.

Responsibilities:

* Help in the preparation of US regulatory affairs documentation requests and assure completeness and quality of each submission:

o Track the status of applications under regulatory review and provides updates to the company.

o Submit, file and distribute internally electronic and hard copies of regulatory affairs documents, USDA, and other government responses in conjunction with departmental Standard Operating Procedures (SOPs) or as directed.

* Coordinate the review of outlines and preparation of submissions to the USDA for products made at the Verona facility.

* Review and update facility documents according to 9 CFR requirements, submit facility documents to the USDA:

o Maintain change control documents for changes.

o Coordinate submissions with all necessary departments.

o File and distribute internally electronic and hard copies of USDA and other government responses in conjunction with departmental SOPs or as directed.

* Prepare Administrative Inspection Review documents when required by CVB, as they relate to the Verona facility.

* Maintain positive and cooperative communications and collaborations with all involved parties.

* Adhere to company and department SOPs:

o Develop and maintain best practices, guidelines, procedures, tools and/or trainings to standardize processes.

o Drive continuous improvement.

o Educate others on regulatory compliance requirements.

* Performs other related duties and responsibilities, on occasion, as assigned.

* Shape solutions out of complexity - Work to evolve immediate environment

* Client focus - Make sure needs and requests are treated equally and in a positive way

* Collaborate with empathy - Fully takes part in the working group to share information, listens to others and have a clear idea of the decisions made

* Engage and develop - Open to share knowledge and to receive feedback from others

* Drive ambition and accountability - Ensure accuracy of work and progress through the use of KPI's

* Influence others - Show confidence when communicating and presenting information

* Ability to development and execute regulatory strategy.

* Ability to work independently while providing guidance and training to others on analyzing data from multiple sources.

* Define appropriate Regulatory Affairs objectives and make suitable recommendations.

* Knowledge of regulatory affairs requirements and guidelines.

* Interpret, follow-up and apply knowledge of registration and development directives, rules and monographs in area of expertise.

* Apply knowledge of quality, safety and efficacy regulatory procedures in an area of expertise.

* Knowledge and know-how regarding dossier preparation, summary writing and dossier follow-up in an area of expertise.

* Ability to network, influence and negotiate with internal and external stakeholders regarding Regulatory Affairs for Ceva best interests.

* Impactful negotiation skills in front of variable size and type of audience.

* Capability to manage stressful situations with internal and external stakeholders.

* Know-how of project coordination and ability to interpret timely financial impacts of Regulatory Affairs decisions on production, supply & marketing.

* Ability and motivation to learn new skills.

* Ability to understand and interpret regulatory and technical documents.

* Apply knowledge from internal and external sources to drive regulatory solutions and enable business objectives.

* Strong attention to detail and capable of delivering quality work with minimal supervision.

* Excellent organizational skills, including the ability to handle multiple assignments.

* Proficiency with Microsoft Office suite, Smartsheet, Google Suite, Adobe.

Education - Bachelor's degree in Biology or similar degree required, graduate level degree preferred

Work Experience - Minimum 2 years regulatory experience in US veterinary biologics and at least 5 years' experience in development, production, and testing animal health vaccines including experience licensing veterinary biologics in the United States.

Other - Knowledge of USDA regulations for Autogenous veterinary biological products. Strong familiarity and working relationship with USDA

• Able to read, write legibly and communicate in English
• Visual inspection

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This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

*VEVRAA Federal Contractor

**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

669B