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.