Summary:
The Regulatory Affairs Specialist II supports the development, approval, and maintenance of animal health products (drug, device, and nutritional) by assisting with regulatory submissions and ensuring compliance with applicable FSA requirements. This position is responsible for compiling, organizing, and submitting documentation for (A)NADA and (J)INAD applications, as well as supporting pre- and post-approval regulatory activities. The Regulatory Affairs Specialist II works under the guidance of Regulatory Affairs Manager to help ensure regulatory compliance and reduce the risk of FDA enforcement activities.
Responsibilities:
- Assist in the preparation and submission of electronic submissions to the FDA Center for Veterinary Medicine (CVM); support the review of technical documentation and help track submission progress through to approval. Help ensure post-approval documentation (e.g. MCSR, DER, 2301) is compiled and submitted under direction.
- Support the review of approved and unapproved product labels, promotional materials, and website content by coordinating with marketing and senior regulatory staff to ensure compliance with applicable regulations.
- Help maintain the FDA Structured Product Labeling (SPL) database by submitting updates, assisting with new listings, and supporting the annual review and certification process. Assist in monitoring and implementing state-specific regulatory and labeling updates.
- Assist with DEA regulatory compliance tasks, including documentation for registration maintenance, quote requests, import/export permits, inventory tracking, and inspection readiness.
- Provide support to cross-functional teams such as Quality, Marketing, Sales and Operations by supplying regulatory documentation and assisting with compliance-related deliverables.
- Assist product development managers with the preparation of technical sections, processing of project invoices, tracking of budgets, and support of nonclinical and clinical regulatory activities.
- Support the review of change controls, labeling updates, and manufacturing changes to determine regulatory impact under the guidance of senior regulatory staff.
- All tasks as requested or assigned.
Qualifications & Requirements:
- Education: Bachelor’s degree in Life Science or related field.
- Experience: 5+ years of experience in pharmaceutical or FDA/CVM related industry or with Master’s degree, 2+ years of experience in pharmaceutical or FDA/CVM related industry.
- Knowledge: Industry knowledge in animal health, compliance, regulatory affairs, quality or clinical.
- Skills: Proficient in Microsoft Office Suite (Word, PowerPoint, Excel, Outlook)
