Regulatory Affairs Specialist - United States

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, developin ...

Job description

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 Heath 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. 

 

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Location: Lenexa, KS

Job Summary and Purpose:

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.   

Responsibilities and Key Duties:

Leadership:

·       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.

 

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 (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.

 

Product Post-Licensure and Life Cycle Management Responsibilities

·       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 compliance with applicable regulation and guidance documents.

·       Support regulatory strategies for new and modified manufacturing processes, facilities, and Quality Systems. Provide regulatory guidance to GID/Prod teams on responsible projects.

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:

·       Demonstrates ability to solve problems and provide proactive resolution.

·       Knowledge 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 1+ years of relevant work experience in the production of pharmaceutical or biologic products strongly preferred. 4+ years of equivalent work experience in development, production or testing of veterinary biologics, including experience using or preparing regulatory documentation supporting veterinary biologics marketing authorizations may be considered in lieu of a degree.

High school diploma/GED 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

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Education and Work Experience - Bachelor's degree in Veterinary, Biology, Microbiology or other science related field with 1+ years of relevant work experience in the production of pharmaceutical or biologic products strongly preferred. 4+ years of equivalent work experience in development, production or testing of veterinary biologics, including experience using or preparing regulatory documentation supporting veterinary biologics marketing authorizations may be considered in lieu of a degree.

High school diploma/GED required.