Job Title: Regulatory Affairs Specialist 

Location: East Brunswick, NJ and Hybrid

Travel Required: <10% 

Salary Range: $70-80K+ and health and other benefits  

Position Type: Full-time 

General Purpose: Provide US regulatory affairs support for all Cronus drug projects. 

Key Responsibilities:

• Serves as the sponsor administrative professional for completion or coordination of all submissions made to US-FDA/CVM using CVM eSubmitter.
• Author and/or collaborates to develop and maintain SOPs.
• Collaborate with partners, manage and maintain online documentation system for all product files. 
• Assist in maintaining all product files in a comprehensive Regulatory file/submission tracking and maintenance system for all product files.
• Complies and supports regulatory file directory structure, naming convention, product file assimilation, and sponsor transfers. 
• Assists in CVM submission support in communication of information to our manufacturing site and CMOs for sponsor products. 
• Review, complete and submit all annual antimicrobial reporting, DERs, MCSR, and Facility Registrations, etc.  
• Perform all drug listings, as applicable, for Cronus and/or distributor labels – original and updates. 
• Support Regulatory Team in other activities such as compendium updates, document due diligence acquisition and coordination with document and samples storage facilities.
• Assist in management, disposition, and lifecycle of inventory status of all study samples. 
• Review and coordinates development and revisions of labels and marketing materials for submissions to CVM.  
• Supports CMC activities in reference label and FOI review, Green Book patent and exclusivity review, trade name selection/filing activities, and FDA databases for product relevant information. 
• Collaborate and support Regulatory Team with PV contractor and manufacturing partners for resolution of product complaints and perform periodic audits of pharmacovigilance cases. 
• Coordinates with PV contractor to routinely provide necessary updates to Cronus library of products for new Cronus products and customer product information.
• CMC and GLP submission review for accuracy, quality, and completeness per regulatory requirements.
• Coordinate and draft agendas, compile data and supporting information for CVM meeting requests.
• Support Regulatory Team and Management in product and regulatory strategy research.
• Participate in educational opportunities to increase knowledge about regulations, guidances and current regulatory policy. 

Qualifications and Education Requirements:

• 3-5 years pharmaceutical industry experience. 
• 3-5 years pharmaceutical regulatory affairs experience. 
• 2-5 years knowledge and experience with FDA regulations and requirements (GLP and GMP). 
• 4 years technical writing and editing. 
• 3-5 years regulatory writing and submission experience. 
• 2+ years project management experience. 

Education 

• BA/BS in technical field or scientific discipline (Veterinary Science, Biology, Bio-chemistry).

Technical

• Experience with Microsoft Office Suite programs, especially Word, Excel, Project. 
• Experience with CVM eSubmitter software.  
• Experience with SharePoint or other document and information management software.
• Project management software experience. 
• Proficient with FDA QbR and SPL programs. 

Behavioral 

• Good written and verbal communication skills. 
• Good organizational and troubleshooting skills. 
• Self-motivated and self-starting. 
• Strong interpersonal and organizational skills. 
• Excellent written and verbal communication skills. 
• Keen attention to detail. 
• Highly adaptable. 

Language 

• English and potentially multilingual, Hinde.