Regulatory Affairs Senior 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
Job Summary and Purpose The position is responsible for supporting submissions for licensed and pre‑licensed veterinary biologics for Ceva Animal Health. This role partners cross‑functionally with QA/QC, Manufacturing, R&D, GID, Supply Chain and Labeling to ensure end‑to‑end compliance—from development through licensure, commercialization, and lifecycle management—under 9 CFR and CVB guidance. The Senior Specialist will work with I&D to determine strategy for licensing, provide regulatory guidance, and prepare submissions to the USDA to support new licenses and maintain existing licenses. You will drive regulatory planning, correspondence authoring, label sketch approvals, Outline of Production (OP) management, and post‑licensure change control for a diverse biologics portfolio (including autogenous, domestic and imported biologics, as applicable).
This position will stay up to date on new regulations to ensure license maintenance, compliance and product life‑cycle management guidelines are maintained and monitor changes to regulations to determine the impact to product development. The ideal candidate combines operational excellence with sound regulatory judgment to anticipate risk, resolve issues with CVB, and deliver business outcomes.
Responsibilities and Key Duties Leadership
Represent CEVA 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 new product licenses.
Support project manager to help drive projects to completion, including assignment of regulatory tasks and deadlines as needed.
Keep abreast of new USDA guidelines and memoranda.
Provide up‑to‑date reports and timelines of projects to keep all departments informed of developments.
Keep track of all versions of documents needed for submission to USDA for licensure.
Build effective working relationships with key business partners, regulators, customers, suppliers and colleagues.
Regulatory Intelligence
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 (new memoranda from USDA).
Utilizing expert technical regulatory skills to influence USDA on complex 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.
Product Licensure and Life Cycle Management
Prepare/ write clear arguments and explanations in order to answer the questions and comments needed from the USDA for new product licenses.
Identifies and communicates potential risks and mitigations associated with regulatory strategies and stakeholders.
Outline of Production governance: annual reviews, change control impact assessments, authoring, version control, and timely CVB submissions.
Ensure compliant records and archiving of regulatory submissions, CVB correspondence, and commitments. Leverage eSystems (e.g., APHIS eFile or company equivalents) where applicable. Ensure that complete up‑to‑date records are maintained for compliance.
Partner with QA/QC/Manufacturing on serial release criteria, potency and stability claims, sterility and purity compliance, and investigations that require regulatory reporting/communication.
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 new vaccines. Staying current with all regulatory related tasks and providing progress updates as needed.
Support postmarketing surveillance obligations (adverse event monitoring and reporting to CVB) and implement signal‑driven label or process updates as needed.
Ensuring the consistency and completeness of the technical regulatory documents for all submissions.
Review and advise regarding the regulatory documentation before submission. Carries the responsibility that data is in full compliance before submission.
Core Competencies and Attitudinal Characteristics
Shape solutions out of complexity - Is open and curious of others perspectives
Client focus - Has in mind clients satisfaction
Collaborate with empathy - Has a positive attitude towards collaboration
Engage and develop - Clarifies short‑term directions
Drive ambition and accountability - Proactively manages own and others work
Influence others - Communicates transparently
Technical / Functional Competencies
Ability to deploy a strategy to anticipate «list of questions, future problems» before submission and capacity to take corrective actions after identifying a risk. Demonstrates problem‑solving attitude and be pro‑active in their resolution.
Knowledge and know‑how regarding regulatory requirements and guidelines, regulatory submission preparation, summary writing and licensure follow‑up. High level of attention to detail.
Ability to network, influence and negotiate with internal and external stakeholders regarding Regulatory Affairs for Ceva best interests.
Demonstrates strong communication skills, both verbal and written. Ability to create impactful presentations, internally and/or externally. Awareness of cultural aspects in communication and interpersonal relationships.
Ability to initiate, plan, prioritize, execute, control, and close the work of a team to achieve goals and meet specific success criteria at the milestones. Ability to work in a fast‑paced environment and possess strong organizational skills to multi‑task and prioritize multiple and diverse projects.
Ability to work independently.
Ability to master the tools & software related to the position.
Solid working knowledge of USDA regulations for veterinary biological products. Knowledge of biotechnology production a plus.
Qualifications Education and Work Experience Bachelor's degree in Veterinary, Biology, Microbiology or other science related field with 4+ years of relevant work experience in the production of pharmaceutical or biologic products
OR
Master's degree in Veterinary, Biology, Microbiology or other science related field with 2+ years of relevant work experience in the production of pharmaceutical or biologic products required.
Physical Requirements
Must be able to read, write legibly and communicate in English
Tasks frequently require prolonged, mental and visual concentration
Working Conditions Work can be remote, with time in the office as needed to ensure continued quality of work and as needed for team functions.
Travel Required Up to 5% of time for business travel, including local, regional and international;
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
#J-18808-Ljbffr
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
Job Summary and Purpose The position is responsible for supporting submissions for licensed and pre‑licensed veterinary biologics for Ceva Animal Health. This role partners cross‑functionally with QA/QC, Manufacturing, R&D, GID, Supply Chain and Labeling to ensure end‑to‑end compliance—from development through licensure, commercialization, and lifecycle management—under 9 CFR and CVB guidance. The Senior Specialist will work with I&D to determine strategy for licensing, provide regulatory guidance, and prepare submissions to the USDA to support new licenses and maintain existing licenses. You will drive regulatory planning, correspondence authoring, label sketch approvals, Outline of Production (OP) management, and post‑licensure change control for a diverse biologics portfolio (including autogenous, domestic and imported biologics, as applicable).
This position will stay up to date on new regulations to ensure license maintenance, compliance and product life‑cycle management guidelines are maintained and monitor changes to regulations to determine the impact to product development. The ideal candidate combines operational excellence with sound regulatory judgment to anticipate risk, resolve issues with CVB, and deliver business outcomes.
Responsibilities and Key Duties Leadership
Represent CEVA 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 new product licenses.
Support project manager to help drive projects to completion, including assignment of regulatory tasks and deadlines as needed.
Keep abreast of new USDA guidelines and memoranda.
Provide up‑to‑date reports and timelines of projects to keep all departments informed of developments.
Keep track of all versions of documents needed for submission to USDA for licensure.
Build effective working relationships with key business partners, regulators, customers, suppliers and colleagues.
Regulatory Intelligence
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 (new memoranda from USDA).
Utilizing expert technical regulatory skills to influence USDA on complex 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.
Product Licensure and Life Cycle Management
Prepare/ write clear arguments and explanations in order to answer the questions and comments needed from the USDA for new product licenses.
Identifies and communicates potential risks and mitigations associated with regulatory strategies and stakeholders.
Outline of Production governance: annual reviews, change control impact assessments, authoring, version control, and timely CVB submissions.
Ensure compliant records and archiving of regulatory submissions, CVB correspondence, and commitments. Leverage eSystems (e.g., APHIS eFile or company equivalents) where applicable. Ensure that complete up‑to‑date records are maintained for compliance.
Partner with QA/QC/Manufacturing on serial release criteria, potency and stability claims, sterility and purity compliance, and investigations that require regulatory reporting/communication.
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 new vaccines. Staying current with all regulatory related tasks and providing progress updates as needed.
Support postmarketing surveillance obligations (adverse event monitoring and reporting to CVB) and implement signal‑driven label or process updates as needed.
Ensuring the consistency and completeness of the technical regulatory documents for all submissions.
Review and advise regarding the regulatory documentation before submission. Carries the responsibility that data is in full compliance before submission.
Core Competencies and Attitudinal Characteristics
Shape solutions out of complexity - Is open and curious of others perspectives
Client focus - Has in mind clients satisfaction
Collaborate with empathy - Has a positive attitude towards collaboration
Engage and develop - Clarifies short‑term directions
Drive ambition and accountability - Proactively manages own and others work
Influence others - Communicates transparently
Technical / Functional Competencies
Ability to deploy a strategy to anticipate «list of questions, future problems» before submission and capacity to take corrective actions after identifying a risk. Demonstrates problem‑solving attitude and be pro‑active in their resolution.
Knowledge and know‑how regarding regulatory requirements and guidelines, regulatory submission preparation, summary writing and licensure follow‑up. High level of attention to detail.
Ability to network, influence and negotiate with internal and external stakeholders regarding Regulatory Affairs for Ceva best interests.
Demonstrates strong communication skills, both verbal and written. Ability to create impactful presentations, internally and/or externally. Awareness of cultural aspects in communication and interpersonal relationships.
Ability to initiate, plan, prioritize, execute, control, and close the work of a team to achieve goals and meet specific success criteria at the milestones. Ability to work in a fast‑paced environment and possess strong organizational skills to multi‑task and prioritize multiple and diverse projects.
Ability to work independently.
Ability to master the tools & software related to the position.
Solid working knowledge of USDA regulations for veterinary biological products. Knowledge of biotechnology production a plus.
Qualifications Education and Work Experience Bachelor's degree in Veterinary, Biology, Microbiology or other science related field with 4+ years of relevant work experience in the production of pharmaceutical or biologic products
OR
Master's degree in Veterinary, Biology, Microbiology or other science related field with 2+ years of relevant work experience in the production of pharmaceutical or biologic products required.
Physical Requirements
Must be able to read, write legibly and communicate in English
Tasks frequently require prolonged, mental and visual concentration
Working Conditions Work can be remote, with time in the office as needed to ensure continued quality of work and as needed for team functions.
Travel Required Up to 5% of time for business travel, including local, regional and international;
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
#J-18808-Ljbffr