Regulatory Affairs Associate

Regulatory Associate / ConsultantRole OverviewWe are looking for a Regulatory Associate/Consultant to support global regulatory projects across pharmaceuticals, biologics, and medical devices. The role involves regulatory strategy support, dossier preparation, submission management, lifecycle activities, and coordination with cross-functional stakeholders across global markets.Key ResponsibilitiesSupport regulatory projects across US, EU, ASEAN, LATAM, India, and other global marketsAssist in regulatory strategy development and market entry pathwaysPrepare, review, and compile regulatory dossiers (CTD, ACTD, eCTD, STED, DMF components)Manage end-to-end submission activities including formatting, documentation, and quality checksSupport lifecycle management activities such as variations, renewals, and regulatory updatesDraft and review responses to regulatory authority queries and deficiency lettersCoordinate with internal teams to ensure timely and compliant project executionTrack project timelines, deliverables, and submission documentationEnsure high-quality, compliant regulatory deliverablesCandidate ProfileEducationB.Pharm / M.Pharm / PharmD / Biotechnology / Life SciencesRegulatory Affairs certifications are an added advantageExperience3–8 years of experience in Regulatory Affairs, Regulatory Operations, or Dossier PreparationExperience in Pharma, Biologics, or Medical Devices preferredRequired SkillsStrong understanding of global regulatory frameworks (FDA, EMA, CDSCO, ASEAN, etc.)Hands-on experience in regulatory submissions and lifecycle managementExpertise in CTD/eCTD/STED dossier preparationStrong analytical, documentation, and problem-solving skillsDetail-oriented with strong quality and compliance focusAbility to manage multiple projects independently

Apply Now