Job ID 5162 Company: Dechra Veterinary Products Job Location Overland Park, KS
Manager (or Sr. Manager) Regulatory Affairs (Overland Park, KS)
Job Requirements* 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.
* College degree required
* Detail orientated
* Collaborative, and able to support multiple tasks concurrently
* Excellent written/verbal communication skills.
* Commercial and Business Acumen
* Project Management
* Problem Solving
* Relationship Management
* Customer Service
* Results Focused
* Product and Technical Knowledge
Job DescriptionDechra 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 or Senior Manager, Regulatory Affairs provides regulatory support and guidance for projects, from inception through development, and post-approval through the product lifecycle. The Manager or Senior Manager, Regulatory Affairs assists with document development and compilation, writes submissions including technical sections, supplements, and meeting requests for assigned projects and products, in addition to assessing change controls for both drug substances and drug products. The Manager or Senior 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, maintenance of critical databases, and that the RA workload is in alignment with project team needs (in control and run efficiently).
View Employer Profile Send to Friend
Please log in to apply for this job.