Regulatory Affairs Specialist jobs in Kansas

The position is responsible for supporting the licensure of new vaccines and new label claims for Ceva Animal Health. The Pre-license RA Specialist will work with I&D to support licensing, provide regulatory information, and prepare submissions to the USDA to support new licenses and maintain existing licenses. Other responsibilities may include, but are not limited to, reviewing protocols and reports prior to submission to USDA to ensure these studies meet the regulatory requirements, completion of regulatory documents related to specific projects and supporting the RA Senior Specialist - prelicense in preparation of submissions. The RA Specialist will work with the project leader and R&D colleagues to help ensure timelines are met for submissions to the USDA.

This position will stay up to date on new regulations to ensure license maintenance, compliance and product life cycle management guidelines are maintained.

• Support project team to progress projects, including drafting of regulatory tasks in accordance with the defined timelines

• Draft and file submissions and responses to and from the USDA. Propose arguments and explanations to answer the questions and comments needed from the USDA for product licenses and life cycle management.

• Update any applicable computer tracking systems (such as a document tracker or planned submissions database).

• Keep track of documents needed for submission to USDA for licensure.

• Build effective working relationships with colleagues.

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

• Work on the implementation of compliance with current regulations (new memoranda from USDA) as directed.

• Taking initiative to learn scientific innovation using multiple resources to expand skills and apply them.

• Prepare/ write clear arguments and explanations in order to answer the questions and comments needed from the USDA for new product licenses.

• Help evaluate 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.

• Providing advice regarding the analytical and clinical study plans needed to support a new license.

• 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. .

• Ensure that complete up-to-date records are maintained for compliance and guarantee of product integrity.

• Support consistency and completeness of the technical regulatory documents for all submissions.

• 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

• Ability to follow a strategy for authority submissions, 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.

• Demonstrates good communication skills, both verbal and written. Ability to create presentations, internally and/or externally.

• 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.

Education - Bachelor's degree in Veterinary, Biology, Microbiology or other science related field. Master's degree in Veterinary, Biology, Microbiology or other science related field preferred.

Work Experience - Two or more years of experience in development, production or testing of veterinary biologics, including experience supporting veterinary biologics marketing authorizations.

Other (consider certifications, specialized knowledge and/or training, etc.) - Knowledge of USDA regulations for veterinary biological products. Knowledge of biotechnology production a plus.

• Must be able to read, write legibly and communicate in English

• Tasks frequently require prolonged, mental and visual concentration

• Work can be remote, with time in the office as needed to ensure continued quality of work and as needed for team functions.

• 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.