What are the responsibilities and job description for the Regulatory Affairs Manager - Pensacola, FL position at Skywalk Group?
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 certifications
Benefits & Perks :
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 service
Position Requirements :
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.
