Cronus Pharma
This full-time on-site role is in East Brunswick, NJ for a Director of Regulatory Affairs at Cronus Pharma. The Director leads regulatory strategy and compliance for generic animal health pharmaceutical products, ensuring 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 the 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 the 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 the animal health pharmaceutical industry 3+ years in leadership or management role Extensive experience with FDA-CVM 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. Seniorities & Employment Details
Seniority level : Director Employment type : Full-time Job function : Legal Industries : Pharmaceutical Manufacturing
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Regulatory Strategy & Leadership Develop and execute regulatory strategies for the 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 the 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 the animal health pharmaceutical industry 3+ years in leadership or management role Extensive experience with FDA-CVM 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. Seniorities & Employment Details
Seniority level : Director Employment type : Full-time Job function : Legal Industries : Pharmaceutical Manufacturing
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