Regulatory Affairs Senior Manager – # 9182

Regulatory Affairs Senior Manager – # 9182

We are searching for a senior-level Regulatory Affairs Manager.  Regulatory Affairs Senior Manager leads regulatory strategy and compliance for animal health pharmaceutical products, ensuring all submissions, registrations, and communications meet FDA-CVM, state, and international regulatory requirements. This role serves as the primary liaison with regulatory agencies and drives the timely approval of veterinary drug applications.

Key Responsibilities

• Develop and execute regulatory strategies for animal health product portfolio
• Lead regulatory team in planning submission timelines, resource allocation, and cross-functional coordination
• Provide strategic regulatory guidance to R&D, Quality, Manufacturing, Supply Chain and Commercial teams throughout product lifecycle
• Assess regulatory risks and develop mitigation strategies for product development and commercialization

• Oversee preparation and submission of annual reports, and other regulatory filings to FDA-CVM
• Manage responses to FDA deficiency letters, information/amendment requests, and FDA-CVM meetings
• Serve as primary contact with FDA-CVM and other regulatory authorities
• Lead regulatory intelligence gathering on guidances, policy changes, and industry trends
• Coordinate minor use/minor species (MUMS) designations and conditional approvals when applicable
• Ensure ongoing compliance with FDA regulations, USP standards, and cGMP requirements

• Oversee regulatory aspects of manufacturing changes, site transfers, and post-approval modifications
• Lead regulatory portions of internal and external audits and inspections
• Maintain veterinary master files and product registration databases

 Required Qualifications

Education & Experience

• Bachelor’s degree in life sciences, pharmacy, veterinary medicine, or related field (advanced degree preferred)
• 5+ years of regulatory affairs experience in animal health pharmaceutical industry
• 3+ years in leadership or management role
• Extensive experience with FDA-CVM submissions

Technical Knowledge

• Deep understanding of FDA-CVM regulations, guidance, and drug development strategies
• Knowledge of veterinary pharmacology, nuances of veterinary product use, and human food safety requirements.
• Understanding of pharmaceutical development, manufacturing, and quality systems

Preferred Qualifications

• DVM or PharmD degree
• Experience with both companion animal and food animal drug products
• Proficiency with regulatory information management systems