Regulatory Affairs Associate

United Consulting Hub is seeking a Regulatory Affairs Associate to support regulatory submissions and compliance activities across the pharmaceutical, biotechnology, life sciences, and medical device industries. The role assists with regulatory documentation, product registrations, submission tracking, and coordination with cross-functional teams.

Responsibilities

• Assist in preparing and maintaining regulatory documents and submission packages
• Support product registration, regulatory submissions, renewals, and amendments
• Maintain regulatory files, databases, and submission tracking records
• Assist in preparing technical documents, product information, and labeling materials
• Monitor regulatory updates and applicable industry guidelines
• Coordinate with QA, QC, R&D, and manufacturing teams to collect required documentation
• Ensure compliance with Good Documentation Practices (GDP) and company SOPs
• Support the preparation of CTD/eCTD regulatory submission dossiers
• Assist with regulatory audits, inspections, and compliance reviews
• Maintain accurate records and ensure timely completion of regulatory activities

Preferred

• Internship or academic project experience in regulatory affairs
• Exposure to regulatory submissions, product registration, or labeling activities
• Familiarity with CTD/eCTD formats or electronic document management systems
• Regulatory Affairs
• Regulatory Submissions
• Product Registration
• Product Labeling
• CTD/eCTD Formats
• Electronic Document Management Systems

Company

• Pharmaceutical, biotech, and medical device validation consulting
• Metuchen, New Jersey, USA
• https://unitedconsultinghub.com/
• Founded in 2021
• 51-200 employees

Qualifications

• Basic understanding of pharmaceutical, biotechnology, or medical device regulations
• Knowledge of FDA, EMA, ICH guidelines, and applicable regulatory requirements
• Familiarity with regulatory documentation and submission processes
• Strong organizational, analytical, and documentation skills
• Good written and verbal communication skills
• Proficiency in Microsoft Word and Excel
• Internship or academic project experience in regulatory affairs
• Exposure to regulatory submissions, product registration, or labeling activities
• Familiarity with CTD/eCTD formats or electronic document management systems

Required skills

• CTD/eCTD, EMA Regulations, FDA Regulations, ICH Guidelines, Microsoft Excel, Microsoft Word, Pharmaceutical, Biotechnology, and Medical Device Regulations, Regulatory Documentation and Submission Processes

Preferred skills

• AI Tools, Analyze How Well You Fit, Babjee M, Build Cover Letter, Company data provided by, Customize Your Resume, Founder, Growth Stage, Leadership Team, Make your application stand out, Maximize your interview chances, Metuchen, New Jersey, USA, Understand your strength & weakness, https://unitedconsultinghub.com

Experience

• Entry level