Associate, 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 Associate, Regulatory Affairs is responsible for ensuring business critical Regulatory processes are both in control and run efficiently. The major processes include those associated with post and pre-approval project submissions (amendments/CBE-0s), annual reports (MCSRs/DERs), and the maintenance of critical regulatory systems. The critical systems are databases which support CVM submission/communication tracking, CMC Indexing, and relevant industry/Agency knowledge. As these databases are utilized by RA, Quality, and Product Development teams, the Senior Associate must be sufficiently integrated with the teams to ensure that all activities which support the regulatory/quality systems are in alignment with their needs and maintained efficiently.
At the direction of the Regulatory Affairs Manager, the Associate will also learn and assist with activities related to submission development (publishing and building eSubmitter frameworks). The Associate will leverage both internal and external resources to ensure the publishing/building activities are completed independently and on time.
The ideal candidate will have familiarity with FDA regulations associated with solid oral and injectable dosage forms, cGMPs, database management, and a working knowledge of change control processes. The candidate must be detail orientated and able to work on multiple tasks concurrently. Familiarity with ADE/PQC (PV Works) regulations and electronic document publishing to support regulatory submissions is helpful.
- Coordinate, prepare and submit annual reports (MCSRs, DERs) to FDA.
- Project manage the development and preparation of various post approval supplements (CBE-0, CBE-30) by providing regulatory strategy to resolve issues and minimize deficiencies.
- Develop, draft and/or review internal and external regulated documentation as required; MSDS, promotional marketing material, labeling, licensing renewals, AGDUFA registration, etc.
- Support function for Vet-Tech Services, Quality, and RA: Manage and track incoming ADE/PQC events internally and externally for submission to FDA.
- Utilize submission/communication tracking systems to accurately reflect submissions and FDA communications. Ensure that all submissions are electronically archived and accessible to Regulatory, Quality, and the Product Development teams.
- Maintain commitment tracking system to accurately reflect all commitments Dechra makes to CVM; appropriately log each commitment and advise RA/PD/QA team of pending due dates for commitments, closed commitments, status of response, and archiving.
- Maintain tracking system to accurately document competitive intel (new ANADA, NADA, DMF, supplement approvals, as well as suitability petitions).
- Assist in the training and growth of junior-level associates.
- Able to bring a creative approach to resolving issues
- Self-motivated, driven, and resourceful
- Highly organized and detail oriented
- Committed to ensuring projects are completed correctly and on time
- College degree preferable
- 2 + yearsrs Regulatory Experience (CVM/CDER experience preferred, EU experience a plus)
- Must have strong interpersonal skills and be adaptable
- Excellent computer skills (MS Office Suite, Adobe, Share Point) and an ability to pick up new systems & software quickly
- Demonstrates strong analytical & organizational skills with the ability to handle multiple tasks and prioritize
- Knowledge of administrative procedures and systems such as word processing, databases, managing files and records, designing forms, and other office procedures and terminology
Occasional travel may be required (domestic and international)