Regulatory Affairs Specialist -CRO

Roles & Responsibilities:
• Compile, review, and author CTD and eCTD dossiers for global submissions
• Perform eCTD publishing and manage submission sequences and lifecycle operations
• Handle product lifecycle activities including variations, renewals, amendments, and compliance updates
• Ensure compliance with current regulatory guidelines and country-specific requirements
• Coordinate with QA, CMC, Clinical, Pharmacovigilance, and Medical Writing teams
• Communicate with Health Authorities and manage deficiency responses
• Track submission timelines, approvals, and regulatory commitments
• Maintain regulatory databases and documentation
• Support audits, inspections, and internal regulatory assessments

Qualification:
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline

Experience:
• 4–6 years of experience in Regulatory Affairs (Pharma/Life Sciences)
• Strong hands-on experience in CTD and eCTD compilation and publishing
• Experience with US, EU, and ROW regulatory submissions
• Experience in lifecycle management and Health Authority interactions

Skills:
• Strong knowledge of global regulatory frameworks
• eCTD publishing expertise
• Good documentation and communication skills
• Ability to manage multiple submissions independently
• Detail-oriented with compliance-focused mindset

About the Organization:
Medifodil Smart Pharma Solutions provides regulatory consulting and dossier management services, supporting global pharmaceutical companies in regulatory submissions and product lifecycle management across multiple markets.