Regulatory Affairs Specialist

Job SummaryWe are seeking a motivated and detail-oriented Regulatory Affairs Specialist with 0–3 years of experience to join our growing team in New York. This entry-level full-time opportunity is ideal for recent graduates and early-career professionals looking to build hands-on experience in regulatory compliance, product submissions, quality documentation, and FDA regulations within the pharmaceutical and medical device industries. The candidate will collaborate with cross-functional teams to support regulatory activities and ensure compliance with industry standards and global regulatory requirements.Key ResponsibilitiesAssist in preparing and maintaining regulatory submissions, filings, and documentation.Support compliance activities related to FDA, ISO, GMP, and other regulatory standards.Review product labeling, technical files, and quality documentation for regulatory accuracy.Maintain regulatory databases, records, and submission trackers.Coordinate with Quality Assurance, Manufacturing, R&D, and Project teams on regulatory activities.Support change control, CAPA, and audit readiness activities.Monitor updates to regulatory guidelines and communicate changes internally.Assist in compiling documents for inspections, audits, and customer requests.QualificationsBachelor’s degree in Regulatory Affairs, Life Sciences, Biology, Chemistry, Biomedical Engineering, Pharmacy, or related field.Basic understanding of FDA regulations, GMP, ISO standards, and regulatory documentation.Strong organizational, communication, and analytical skills.Proficiency in Microsoft Office Suite and document management systems.Ability to work in a fast-paced, team-oriented environment.Preferred SkillsInternship or academic project experience in pharmaceuticals, biotech, or medical devices.Familiarity with 21 CFR Part 11, CAPA, change control, or validation processes is a plus.Strong attention to detail and documentation practices.