Manager Regulatory Affairs Pre-Approval Pharma

Carryout and oversee regulatory activities to support the development, registration, and approval of new animal products under FDA/CVM by being a core team member on Global and US development teams. Primary emphasis is on Safety and Effectiveness, with a secondary emphasis on Chemistry, Manufacturing and Controls.

• Prepare regulatory assessments for project teams, line management, and key stakeholders as requested. Includes support for due diligence evaluations.
• Subject matter expert on current US FDA/CVM regulatory requirements for new animal drugs, with focus on Effectiveness and Safety and candidates with additional knowledge of CMC being highly encouraged.
• Interface with regulatory authorities on new product development and registration programs, as well as industry associations.
• Serve as Regulatory Affairs, Global Development Team member that proactively provides regulatory strategies and pathways contributing to the optimum development, registration, and approval of new products. Able to lead and/or support project teams in this capacity as assigned.
• Proactively monitor, evaluate, communicate existing and new US regulations impacting products and projects. Assess the potential impact and/or opportunities.

• Prepare timely, well written regulatory submissions with appropriate content, organization, clarity, and completeness. Includes submissions for pre-development / pre-submission meetings, dossiers / technical sections, amendments, and reactivations. Accurate review and assessment of the suitability for prepared submissions.

• Represent Ceva’s interests in industry associations (e.g., AHI Working Groups)
• Maintain database(s) for tracking regulatory correspondence, communications, submissions, critical dates, and commitments. Ability to effectively use FDA/CVM submission system (E-submitter).
• Coordinate technical input for preparation / review of FOI summary and label language for assigned projects.

• Shape Solutions out of Complexity - Keen on listening to other trends and ideas to enrich solutions and perspectives. Proactively debate and propose changes to make the processes and the ways of working simpler.

• Client Focus - Enable clear communication in order to respond accurately to any concerns and needs. Make sure every need and request are treated equally and in a positive way.

• Collaborate with Empathy- Proactively act in a collaborative way. Demonstrate an open-minded approach towards the other team members to show respect and to support others' input. Fully take part in the working group to share information, listen to others and have a clear idea of the decisions taken.

• Engage and Develop - Create an environment where transparency and regular communication reign to enhance awareness and efficiency. Open to share her/his knowledge and to receive feedback from others.

• Drive Ambition and Accountability - Ensure accuracy of his/her work through the use of KPI’s and a responsible commitment.

• Influence Others - Express oneself with transparency, honesty, and relevant data. Show structure, confidence, and an ability to synthesize while speaking.

• Ability to apply expertise to act as the organizational authority on analyzing data from multiple sources to define appropriate Regulatory Affairs strategy and to make suitable recommendations.

• Ability to act as the organizational authority and established expert on interpreting, following-up and applying knowledge of registration and development directives. Ability to anticipate cause / effects during development and pre-submission.

• Capacity to work independently and provide guidance and training to others while interpreting, following-up and applying knowledge of efficacy, safety, and quality regulatory procedures.

• High level knowledge of registration dossier preparation for US FDA/CVM. Including development, drawing conclusions and effect of changes.

• Ability to make impactful presentations in front of audiences including regulatory authorities, KOL’s and top management of company. Ability to deliver vertical back and forth communication between management and project teams.

• Know-how of project coordination (tasks links and critical path, inter-project management). Ability to interpret timely financial impacts of Regulatory Affairs decisions on production, supply & marketing and impacts on Summary of Product Characteristics and claims.

• Ability to use FDA e-submission tools, archiving tools according to local requirements, and advanced use of main Microsoft Office suite tools and Adobe.

Education – Degree(s) in relevant scientific field (BS/MS/PhD) from an accredited institution with an appropriate certification in Regulatory Affairs.

Work Experience – Minimum of 10 years pharmaceutical experience, with at least 5 years in FDA/CVM Regulatory Affairs responsibilities for development and registration of veterinary drug products. Direct knowledge and proven experience in that resulted in FDA drug approval(s). The ideal candidate has work experience in a wide array of drug development and registration topics (e.g., efficacy, safety, CMC, labeling, protocols for GLP and GCP studies, Human Food Safety, adaptive design studies). Experience with biopharma products or other regulatory agencies governing animal products (e.g., EMA, EPA, USDA) is a bonus.

Must possess the ability to read, speak, hear, and understand English. Must be able to speak, hear and see.

Ability to work remotely. May be required to travel into the home office in Lenexa, KS 1 week per month.

Not more than 10%. May include infrequent international travel.

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.