Manager, Regulatory Affairs
Dechra Pharmaceuticals | Overland Park, KS
Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high quality products exclusively for veterinarians worldwide.
The Manager, Regulatory Affairs provides regulatory support and guidance for projects from inception through development and post-approval work for various submission types to ensure on time submissions. The Manager, Regulatory Affairs compiles documentation and writes technical sections for assigned NADAs, ANADAs, PASs, and CBE-30s, develops CVM meeting requests, and assesses change controls for both drug substance and drug product. The Manager, Regulatory Affairs utilizes a thorough understanding of FDA requirements and processes to support multiple products/projects simultaneously.
- Establish and create an ongoing working knowledge base of FDA/CVM requirements through CVM policy changes and learnings, from CVM feedback on submissions, and industry working groups.
- Ensure that all project stakeholders (both internal and external) understand the regulatory requirements for their projects.
- Work closely with the Director, Regulatory Affairs and Product Development teams to help identify and implement strategies needed to meet requirements for filings.
- Ensure on-time submissions, critical databases are maintained, and that the RA workload is in alignment with project team needs (in control and run efficiently).
- Detail orientated
- Collaborative, and able to support multiple tasks concurrently
- Excellent written/verbal communication skills.
Knowledge and Experience
- College degree required
- 5 - 8 years of experience with FDA regulations; CVM specific experience preferred.
- Must have a working knowledge of pre and post approval submissions for solid oral and injectable dosage forms, APIs, cGMPs
- Familiarity with ADE/PQC (PV Works) regulations and electronic document publishing to support regulatory submissions is helpful.
Able to travel internationally (15%)