Regulatory Consultant (CMC-EU, GCC & AU)

📋 Description Independently manage regulatory activities for standard and complex submissions, aligning with Conduct regulatory research and gap analyses to support development strategies, regulatory plans Prepare administrative and technical components of regulatory submissions, including pre-approval Support briefing documents, agency meeting materials, and regulatory interactions with health Manage daily regulatory project activities per timelines, scope, budgets, and objectives. Provide regulatory expertise within multidisciplinary project teams across product lifecycle. 🎯 Requirements Proven experience in regulatory affairs, specifically CMC across global markets. Strong understanding of regulatory submission processes, product registrations, lifecycle Experience supporting regulatory activities within EU, GCC, and Australian markets desired. Ability to analyze regulatory requirements, identify gaps, and develop practical submission Experience with multidisciplinary teams in pharma/biotech/life sciences environments. Strong knowledge of global regulatory guidelines and compliance expectations. 🎁 Benefits Fully remote work opportunity from India with flexibility depending on business needs. Opportunity to contribute to global healthcare projects and life-changing therapies. Exposure to international regulatory environments and complex development programs. Collaboration with professionals across clinical, technical, and regulatory disciplines. Career development through training, mentorship, and continuous learning. Inclusive, collaborative culture focused on innovation and impact.