Develop, prepare, review, and submit regulatory dossiers, product registrations, license renewals, and variations in accordance with country-specific regulatory requirements and international compliance standards.
Monitor global regulatory guidelines, legislation, and industry updates to ensure products remain compliant throughout their lifecycle while proactively assessing the impact of regulatory changes on business operations.
Collaborate with research and development, quality assurance, manufacturing, supply chain, and commercial teams to support product launches, regulatory submissions, and post-market compliance activities.
Maintain regulatory documentation, technical files, labeling records, certificates, and product registration databases while ensuring accuracy, completeness, and timely updates across multiple regions.
Communicate with health authorities, regulatory agencies, notified bodies, and external partners to address regulatory queries, obtain approvals, and facilitate successful product registrations.




Support internal audits, external inspections, compliance assessments, and quality management activities by preparing regulatory documentation and ensuring adherence to applicable regulations.
Evaluate product changes, manufacturing modifications, labeling revisions, and documentation updates to determine regulatory impact and recommend appropriate submission strategies.
Prepare regulatory reports, monitor submission timelines, identify compliance risks, provide regulatory guidance to cross-functional teams, and contribute to continuous improvement initiatives supporting global business expansion.

Disclaimer : This job posting has been aggregated from external source. Role detailscontentand availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Global Regulatory Affairs Specialist Mumbai (India)
🏢 KBD Talent Forge India
📍 India