Regulatory Affairs Specialist

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. 


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


  • 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. 


  • 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. 


  • English and potentially multilingual, Hinde.  

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