OTC Product Compliance Manager

OTC Product Compliance Manager

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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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OTC Product Compliance Manager

Location: Remote, United States

The overall responsibility is to provide regulatory assessments and ensure the on-going compliance of the US over the counter (OTC) product portfolio for companion animals (e.g., behavior modification products, dermatological products, supplements, and foods). Collaborating with the Director, US Commercial Compliance, the manager will provide guidance to the business and legal teams on potential compliance issues.

Responsibilities and Key Duties:

1) Provide compliance reviews for OTC product labels, ads, and promotional material according to the applicable regulations.

2) Ensure the appropriate permits, licenses, and registrations are secured and maintained for the OTC product portfolio (e.g., state licenses, establishment registrations).

3) Execute compliance activities like drug listings, establishment registrations, and state licenses promptly with the appropriate agency.

4) Maintain Ceva's product dictionary (EMMA) to assure accurate and timely entries for the OTC products.

5) Support the launch of new OTC products.

6) Work closely with other departments, including Non-Pharma / OTC R&D, to inform and advise on the US federal and state requirements for the distinct categories of OTC products.

7) Work closely with the US R&D Regulatory Affairs department on the classification / categorization of proposed new OTC products or proposed new uses for existing OTC products.

8) Prepare change control assessments and support the life cycle management of the OTC product portfolio.

9) Establish a network of experts and industry associations that can aid in the monitoring and assessment of existing, new and/or changing federal and state requirements for products within the OTC portfolio.

Core Competencies:

* Shape solutions out of complexity.

* Client focus

* Collaborate with empathy.

* Engage and develop.

* Drive ambition and accountability.

* Influence others

Technical / Functional Competencies:

* Development and execution of regulatory strategy - Ability to deploy a strategy and clearly articulate the governing requirements, assess gaps and potential compliance risks.

* Regulatory Affairs requirements and guidelines knowledge - Knowledge of products and regulations / requirements and the capacity to respect them.

* Technical Product Development Knowledge - Know-how in safety and effectiveness regulatory procedures in the correct regulatory agency for all Ceva US OTC products.

* Networking and Influencing: Negotiating - ability to network, influence and negotiate with internal and external stakeholders regarding Regulatory Affairs for Ceva's interests.

* Communication and Presentation Skills - ability to use English through verbal and written communication and capacity to create impactful presentations, internally and externally.

* Project Management - 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.

* IT skills/tools - ability to master the tools and software related to the position.

Qualifications:

Education - BA/BS required (Scientific discipline preferred).

Work Experience - Minimum of 5 years industry experience with the management of animal supplement foods and unapproved drugs used for topical management of skin disorders.

Other - Expert knowledge of regulations governing animal supplements, food products, unapproved drugs, and grooming aid products. Extensive knowledge of AAFCO & FSMA feed requirements. Knowledge or experience with the Consumer Product Safety Commission is a plus. Demonstrated ability to learn and understand regulations and navigate through bureaucratic processes.

Physical Requirements:

Ability to read, speak and understand English. Must be able to read, speak, hear, and see.

Working Conditions:

Ability to work remotely up to 80% of the time.

Travel Required:

Travel required up to 10% of the time. Mostly domestic but may require a few international trips.

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.
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Qualifications:

Education - BA/BS required (Scientific discipline preferred).

Work Experience - Minimum of 5 years industry experience with the management of animal supplement foods and unapproved drugs used for topical management of skin disorders.

Other - Expert knowledge of regulations governing animal supplements, food products, unapproved drugs, and grooming aid products. Extensive knowledge of AAFCO & FSMA feed requirements. Knowledge or experience with the Consumer Product Safety Commission is a plus. Demonstrated ability to learn and understand regulations and navigate through bureaucratic processes.