Regulatory Associate

Regulatory AssociateOverview: The Regulatory Associate will support the preparation, review, and submission of regulatory documentation to ensure compliance with global health authority requirements. This role works closely with cross-functional teams—including Quality, Manufacturing, R&D, and Project Management—to support product approvals, amendments, and ongoing regulatory maintenance throughout the product lifecycle.Key Responsibilities:Prepare, compile, and format regulatory submissions (e.g., INDs, NDAs, ANDAs, BLAs, CTAs, annual reports, variations, supplements) in accordance with FDA, EMA, and other global regulatory requirements.Support regulatory strategy by providing input, conducting research on regulatory guidelines, and assisting in gap assessments.Maintain regulatory documentation systems, ensuring timely and accurate updates in compliance databases and tracking tools.Review technical documents for accuracy, clarity, and consistency prior to regulatory submission.Collaborate with cross-functional departments to gather data and ensure regulatory-compliant documentation related to manufacturing, testing, validation, and product change controls.Monitor and interpret regulatory changes, guidance, and industry standards; communicate relevant updates to internal stakeholders.Support regulatory inspections and audits by providing documentation and responding to regulatory requests.Qualifications:Bachelor’s degree in Life Sciences, Chemistry, Biology, Pharmacy, or related field.1–3 years of experience in regulatory affairs within the pharmaceutical, biotech, or medical device industry.Strong understanding of FDA, ICH, and global regulatory guidelines.Excellent technical writing, organizational, and communication skills.Ability to manage multiple deadlines and work cross-functionally in a fast-paced environment.Experience with eCTD publishing tools and regulatory information systems is a plus.Preferred Skills:Prior experience in a GMP manufacturing environment.Familiarity with CMC documentation and regulatory requirements for product lifecycle management.Strong attention to detail and critical thinking skills.