Senior Manager of Regulatory Affairs

Company Description

Cronus Pharma is a fully integrated animal health pharmaceutical company headquartered in East Brunswick, NJ, specializing in Research & Development, Manufacturing, and Marketing. The company is committed to providing high-quality and affordable pharmaceuticals for companion, equine, and production animals. Cronus Pharma's products are designed to be accessible to veterinarians and pet owners through national and regional distributors. Its mission is driven by a focus on meeting the needs of the animal health market with excellence and innovation.

Role Description

This is a full-time on-site role located in East Brunswick, NJ, for a Senior Manager of Regulatory Affairs. The Senior Manager of Regulatory Affairs leads regulatory strategy and compliance for generic 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 generic veterinary drug applications.

Key Responsibilities

Regulatory Strategy & Leadership

• Develop and execute regulatory strategies for generic animal health product portfolio, including ANADAs (Abbreviated New Animal Drug Applications) and supplemental applications
• 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

Submissions & Agency Interactions

• Oversee preparation and submission of ANADAs, supplements, 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

Compliance & Quality Systems

• 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

Generic Product Expertise

• Guide bioequivalence and biowaiver strategies for generic veterinary products
• Collaborate with R&D for comparative study strategiesand analytical method development supporting generic applications
• Provide regulatory strategy based on reference listed drug information for generic drug development and labeling content.
• Manage product lifecycle including label updates, post-approval supplement strategies and various reporting.

Team Management & Development

• Build and mentor regulatory affairs team, providing technical guidance and career development.
• Establish SOPs, best practices, and training programs for regulatory operations
• Foster collaboration across departments and external partners (CMOs, consultants, CROs)

Required Qualifications

Education & Experience

• Bachelor's degree in life sciences, pharmacy, veterinary medicine, or related field (advanced degree preferred)
• 3 years of regulatory affairs experience in animal health pharmaceutical industry
• 2 years in leadership or management role
• Extensive experience with FDA-CVM (Center for Veterinary Medicine) submissions, particularly CMC and Bioequivalence for ANADA applications.

Technical Knowledge

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

Skills & Competencies

• Proven track record of successful ANADA approvals
• Excellent written and verbal communication skills for regulatory documents and agency interactions
• Strong project management abilities with attention to detail
• Strategic thinking with ability to balance scientific, business, and regulatory considerations

Preferred Qualifications

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

This position offers the opportunity to shape regulatory strategy for a growing generic animal health portfolio while ensuring safe, effective, and affordable veterinary medicines reach the market.