Job ID 4528 Company: Dechra Veterinary Products Job Location Portland, ME
Manager, Regulatory Affairs (Portland, ME)
Job RequirementsCollege 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.
Collaborative, and able to support multiple tasks concurrently
Excellent written/verbal communication skills.
Able to travel internationally (15%)
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, 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 Module 2/Module 3 eCTD sections for ANADAs, PASs, and CBE-30s, develops CVM meeting requests, assists with launch initiatives, 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 Senior Manager, 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).
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