Regulatory Affairs Associate

Virtue America is hiring an entry-level Regulatory Affairs Associate to support regulatory submissions, product registrations, and compliance documentation in the pharmaceutical and life sciences industry. The role assists with document preparation and control, regulatory research, submission tracking, labeling reviews, and coordination with cross-functional teams.

Responsibilities

Regulatory Submission Support: Assist in compiling, formatting, and reviewing documents required for regulatory submissions, product approvals, and registration applications

Regulatory Documentation: Organize product dossiers, technical reports, labeling documents, product specifications, and supporting records to ensure completeness and accuracy

Submission Coordination: Track submission deadlines, document requests, review milestones, and regulatory commitments to help maintain project timelines

Regulatory Research: Research applicable FDA requirements, guidance documents, and industry regulations relevant to pharmaceutical products and life sciences operations

Product Labeling Review: Support the review of product labels, package inserts, and promotional materials for consistency with approved product information and applicable requirements

Document Control: Maintain current versions of regulatory documents, submission records, approval letters, and correspondence using established document management procedures

Change Management Support: Assist with evaluating documentation requirements for product changes, manufacturing updates, formulation changes, and labeling revisions

Compliance Monitoring: Help identify updates to relevant regulatory guidance and communicate potential documentation or compliance impacts to the regulatory team

Cross-Functional Coordination: Collaborate with Quality Assurance, Quality Control, Clinical Research, Manufacturing, and Research and Development teams to collect accurate regulatory information

Regulatory Tracking: Maintain trackers, status reports, and submission logs to monitor application progress, renewal dates, and outstanding documentation

Audit and Inspection Readiness: Ensure regulatory files are complete, organized, traceable, and readily available for internal reviews and regulatory inspections

Preferred

Academic projects, internships, or exposure to regulatory documentation, pharmaceutical quality systems, clinical research documentation, or drug registration activities

Regulatory Documentation

Pharmaceutical Quality Systems

Clinical Research Documentation

Drug Registration

Benefits

Remote work

Company

Comprehensive staffing solutions for pharmaceutical, biotech, and medical device industries

Morris Plains, New Jersey, USA

https://virtueamerica.co/

Founded in 2011

51-200 employees

Qualifications

Bachelor's or Master's degree in Pharmaceutical Sciences, Pharmacy, Biotechnology, Biomedical Sciences, Chemistry, Biology, Regulatory Affairs, or a related life sciences discipline

Basic understanding of pharmaceutical product development and regulatory approval processes

Familiarity with FDA regulations, regulatory guidance documents, and pharmaceutical compliance concepts

Awareness of regulatory submission formats, including the Common Technical Document (CTD) and electronic CTD (eCTD)

Basic knowledge of Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Documentation Practices (GDP)

Strong technical writing, document review, and information management skills

Excellent attention to detail and the ability to manage multiple deadlines

Proficiency in Microsoft Word, Excel, PowerPoint, and electronic document management systems

Strong communication, organizational, analytical, and problem-solving abilities

Academic projects, internships, or exposure to regulatory documentation, pharmaceutical quality systems, clinical research documentation, or drug registration activities

Required skills

Pharmaceutical Product Development and Regulatory Approval, FDA Regulations and Guidance, Common Technical Document (CTD), Electronic Common Technical Document (eCTD), cGMP, GCP, and GDP, Pharmaceutical Regulatory Compliance, Microsoft Word, Microsoft Excel, Microsoft PowerPoint

Preferred skills

Analytical and Problem-Solving Skills

Experience

Entry level