Regulatory Affairs Specialist

Roles & Responsibilities
• Provide U.S. regulatory affairs support for all drug projects
• Prepare, coordinate, and submit filings to US FDA – CVM using CVM eSubmitter
• Author, review, and maintain SOPs and regulatory documentation
• Manage regulatory submission tracking systems and product files
• Ensure compliance with regulatory file structures, naming conventions, and sponsor transfers
• Submit annual antimicrobial reports, DERs, MCSR, Facility Registrations, and drug listings (original & updates)
• Support CMC activities including label review, FOI review, Green Book patent/exclusivity checks, and trade name filings
• Review CMC and GLP submissions for accuracy and completeness
• Coordinate pharmacovigilance (PV) activities and product complaint resolution
• Assist in lifecycle management of study samples and regulatory inventory
• Review and coordinate label and marketing material submissions to CVM
• Draft agendas and compile supporting data for CVM meeting requests
• Support regulatory strategy research and compliance initiatives
• Participate in regulatory education and policy updates

Qualification
• BA/BS in Veterinary Science, Biology, Biochemistry, or related scientific discipline

Experience
• 3–5 years pharmaceutical industry experience
• 3–5 years regulatory affairs experience
• 2–5 years experience with FDA regulations (GLP & GMP)
• 3–5 years regulatory writing and submission experience
• 4 years technical writing/editing experience
• 2+ years project management experience

Skills

Technical Skills
• Proficiency in MS Office (Word, Excel, Project)
• Experience with CVM eSubmitter software
• Familiarity with SharePoint or document management systems
• Knowledge of FDA QbR and SPL programs
• Experience with regulatory tracking and project management tools

About the Organization
Cronus Pharma LLC is a U.S.-based veterinary pharmaceutical company focused on delivering high-quality and affordable animal health products while maintaining strong regulatory compliance and global standards.