Regulatory Affairs Manager - Pensacola, FL
: Job Details :

Are you a regulatory expert with a passion for animal health?Pegasus Laboratories, Inc., a leading innovator in veterinary pharmaceuticals and medical products, is hiring a Regulatory Affairs Manager to join its team on-site in Pensacola, FL.As the Regulatory Affairs Manager, you'll leverage your regulatory expertise to secure new animal drug approvals and maintain existing products. You will oversee NADA and ANADA submissions, evaluate materials for compliance, and manage pre- and post-approval projects to ensure regulatory adherence and minimize FDA enforcement risks.Position Responsibilities: •Partner with product development managers to prepare and submit pre-approval technical sections, manage project invoices and budgets, and support in-life study activities as needed•Manage electronic submissions and associated technical documentation, ensuring post-approval regulatory requirements and commitments are met•Assess product changes, including labels and manufacturing modifications, to determine submission requirements and ensure compliance•Collaborate with marketing as a subject matter expert to provide guidance and conduct annual reviews of all approved and unproved product labels, promotional materials, and website content•Oversee FDA Structured Product Labeling (SPL) database, maintaining accurate product listings and certificationsBenefits & Perks: •Competitive Compensation•Comprehensive Healthcare Coverage•Flex Spending Account•401(k) Retirement Plan•Disability Insurance•Pet Insurance•Employee Stock Ownership Plan (ESOP) o What is ESOP? It's an ownership stake in the company that provides an additional form of compensation directly tied to PBI-Gordon's financial success. All regular employees are eligible to participate in the ESOP and will be partially vested after two years with the companies; all employees are 100% vested after six years of servicePosition Requirements: •Bachelor's or Master's degree 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•Experience in animal health, new product development, and FDA/CVM regulatory affairs preferred•Pharmaceutical experience in a cGMP environment and basic knowledge of GMP and FDA regulations is preferred•Familiarity with eSubmitter, Microsoft Dynamics 365 or related ERP systems, and Master Control is preferred•Proficient in Microsoft Office Suite (Word, PowerPoint, Excel, Outlook)Join our team and help shape the future of animal health by ensuring our products adhere to the highest regulatory standards-apply today!This organization is an Equal Employment Opportunity employer and a supporter of affirmative action with a strong commitment to diversity, equity, and inclusion. All qualified applicants are considered for employment without regard to membership in any protected class by federal, state, and/or local laws.