At PBI-Gordon Companies, and our subsidiaries PBI-Gordon Corporation, Pegasus Laboratories, and PetAg, Inc, our priority is people, pets, and the places they go. As employee owners, we support each other in building our careers as well as our companies. Our foundation is rooted in integrity, innovation, partnership, and pride. Come grow with us!
The Regulatory Affairs Manager utilizes regulatory expertise to achieve new animal drug product approvals and maintain currently approved products on the market. This position compiles, reviews and evaluates acceptability of materials for NADA and ANADA regulatory submissions, providing technical and tactical regulatory operations required to manage pre- and post-approval projects and submissions to ensure regulatory compliance and reduce risk of FDA enforcement action.
RESPONSIBILITIES:
- Work with product development managers to prepare and submit major and minor pre-approval technical sections, process project related invoices, track project budgets, and assist with in-life study activities as needed.
- Prepare and submit electronic submissions, review associated technical documentation, and ensure all post-approval regulatory requirements and commitments are met (MCSR, DER, 2301). Engage with CVM on submissions when necessary, and track through full submission process to approval.
- Evaluate pre- and post-approval change controls, labels, manufacturing changes, etc. to determine impact and submission requirements to align with regulatory strategies.
- Partner with marketing as subject matter expert to provide guidance and perform annual review of all approved and unapproved product labels, promotional materials, and website content.
- Work cross-functionally across Quality, Marketing, and Sales as a subject matter expert on regulatory requirements on department-specific deliverables. Shapes submission decisions, anticipates regulatory challenges, and reduces risk.
- Manage the FDA Structured Product Labeling (SPL) database: create new listings, submit updates, perform annual review and certification.
- Actively engage with internal stakeholders, external stakeholders, and industry alliances to remain knowledgeable of industry changes and regulatory environment.
- All tasks as requested or assigned.
QUALIFICATIONS AND REQUIREMENTS:
- B.S. or M.S. with 8+ years’ experience in pharmaceutical or FDA/CVM related industry; DVM or PhD with 5+ years’ experience in pharmaceutical or FDA/CVM related industry
- Preferred experience in animal health industry, new product development, and FDA/CVM regulatory affairs.
- Proficient in Microsoft Office Suite (Word, PowerPoint, Excel, Outlook)
- Experience using eSubmitter, Microsoft Dynamics 365 or related ERP, and Master Control preferred.
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