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Job description
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 Director of Regulatory Affairs. The Director 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 strategies and 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)
6+ years of regulatory affairs experience in animal health pharmaceutical industry
3+ 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
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.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.