Position OverviewWe are seeking a detail-oriented and experienced Regulatory Affairs Officer to join ourSupply Chain and Logistics team. This is a critical high-priority hire intended to bolsterour compliance department ahead of several major upcoming audits. You will beresponsible for managing certifications, ensuring adherence to internationalmanufacturing standards, and providing mentorship to junior staff as the organizationscales its operations.Key Re
Position OverviewWe are seeking a detail-oriented and experienced Regulatory Affairs Officer to join ourSupply Chain and Logistics team. This is a critical high-priority hire intended to bolsterour compliance department ahead of several major upcoming audits. You will beresponsible for managing certifications, ensuring adherence to internationalmanufacturing standards, and providing mentorship to junior staff as the organizationscales its operations.Key Re
Regulatory submissions to health authorities worldwide; Support submission planning including applying intelligence and develop regulatorystrategy Support preparation and maintenance of regulatory files Support submission of regulatory files, response to questions from health authorities andmaintenance of marketing authorisations globally, e.g.: MAA/NDA/BLA, NBO, CE, CTA/IND, Device File, Site Master File, renewals, postapproval changes and commitments
Regulatory submissions to health authorities worldwide; Support submission planning including applying intelligence and develop regulatorystrategy Support preparation and maintenance of regulatory files Support submission of regulatory files, response to questions from health authorities andmaintenance of marketing authorisations globally, e.g.: MAA/NDA/BLA, NBO, CE, CTA/IND, Device File, Site Master File, renewals, postapproval changes and commitments
Job Title: Regulatory Affairs (Medical Devices)Job DescriptionThe RA oversees market access and regulatory strategy, holding authority for global submissions, planning regulatory pathways, managing lifecycle approvals, and engaging with regulatory authorities, with a focus on global regulatory strategy. • Management of product registrations. • Ownership of technical documentation. • Preparedness for market access. Roles & Responsibility:Regulatory Affairs
Job Title: Regulatory Affairs (Medical Devices)Job DescriptionThe RA oversees market access and regulatory strategy, holding authority for global submissions, planning regulatory pathways, managing lifecycle approvals, and engaging with regulatory authorities, with a focus on global regulatory strategy. • Management of product registrations. • Ownership of technical documentation. • Preparedness for market access. Roles & Responsibility:Regulatory Affairs
Senior Regulatory Affairs Officer - Vapi, GujaratWe are seeking a highly experienced and proactive Senior Regulatory Affairs Officer to join our team in Vapi, Gujarat. The ideal candidate will possess a strong background in regulatory affairs and a proven track record of success in preparing and submitting regulatory dossiers. This is a full-time, permanent position that offers a professional and formal work environment.Job Title: Sr. Regulatory Affairs Of
Senior Regulatory Affairs Officer - Vapi, GujaratWe are seeking a highly experienced and proactive Senior Regulatory Affairs Officer to join our team in Vapi, Gujarat. The ideal candidate will possess a strong background in regulatory affairs and a proven track record of success in preparing and submitting regulatory dossiers. This is a full-time, permanent position that offers a professional and formal work environment.Job Title: Sr. Regulatory Affairs Of