Regulatory Affairs Associate

RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking a Regulatory Associate to work with our growing Regulatory Affairs Team  as we scale towards commercial manufacturing in the next upcoming months.? As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team.
 

This position is located in East Windsor, NJ and is required to be onsite. 

If this sounds interesting to you, it's probably because up to this point you have:

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field. 
• 1–3 years of experience in Regulatory Affairs within a pharmaceutical or GMP-regulated environment. 
• Knowledge of FDA, ICH, and cGMP regulations governing pharmaceutical manufacturing and submissions. 
• Experience supporting ANDA, NDA, DMF, and annual report submissions preferred. 
• Familiarity with eCTD format, CMC documentation, and labeling compliance. 
• Strong attention to detail, organizational, and documentation skills. 
• Proficiency in Microsoft Office and regulatory submission tools. 
• Excellent written and verbal communication skills. 

The main expectations and responsibilities for this position are:

• Prepare, review, and maintain regulatory documentation to support product registration, renewal, and lifecycle management. 
• Assist in compiling and formatting CMC sections of submissions (ANDA, supplements, annual reports). 
• Maintain and update regulatory databases and tracking systems to ensure document accuracy and traceability. 
• Review technical and quality documents (batch records, specifications, validation reports) for regulatory consistency. 
• Coordinate with Formulation, Analytical, Quality, and Manufacturing teams to collect required submission data. 
• Ensure compliance with FDA, ICH, and global regulatory requirements in all submissions and correspondences. 
• Support labeling updates, artwork reviews, and promotional material approvals as per regulatory guidelines. 
• Assist in responding to regulatory queries and deficiency letters under supervision. 
• Monitor regulatory changes and guidance updates that impact product filings and compliance. 
• Maintain organized and audit-ready regulatory documentation and correspondence archives. 

If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation.

We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.

WE ARE SLATING THESE HIRES FOR START DATES IN APRIL OF 2026 BUT ARE COLLECTING APPLICATIONS NOW,

NEXT STEPS WILL BE SENT TO YOU IN EARLY FEBRUARY 2026

ONSITE INTERVIEWS WILL BE SCHEDULED IN MARCH 2026

START DATES IN APRIL 2026

RK Pharma Inc is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status