Regulatory Affairs Director

Cronus Pharma; East Brunswick Township (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

A leading animal health pharmaceutical company in East Brunswick, NJ is looking for a Director of Regulatory Affairs. This full-time position involves leading regulatory strategy and compliance for generic veterinary products and acting as the primary liaison with regulatory agencies. Candidates should have significant experience in regulatory affairs and a solid understanding of FDA requirements. This role allows for significant impact on drug approvals and ensuring the availability of affordable veterinary medicines.

Qualifications

• 6+ years of regulatory affairs experience in animal health pharmaceutical industry.
• 3+ years in a leadership or management role.
• Deep understanding of FDA-CVM regulations and generic drug development strategies.
• Extensive experience with FDA-CVM submissions, particularly CMC and Bioequivalence for ANADA.

Responsibilities

• Develop and execute regulatory strategies for generic animal health products.
• Lead regulatory team in planning submission timelines.
• Provide strategic regulatory guidance to R&D and other teams.
• Oversee ANADA submissions, supplements, annual reports, and responses to FDA‑CVM letters.
• Maintain veterinary master files and product registration databases.

Skills

FDA-CVM submissions

Regulatory strategy

Project management

Excellent written and verbal communication

Regulatory submissions

Agency interactions

Regulatory intelligence

Education

Bachelor's degree in life sciences, pharmacy, veterinary medicine, or related field

DVM or PharmD (preferred)

Tools

Regulatory information management systems

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.