Regulatory Affairs Specialist

Roles & Responsibilities
• Compile, review, and author regulatory dossiers in CTD and eCTD format 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 regulatory submissions comply with current guidelines and country-specific requirements
• Coordinate with cross-functional teams such as QA, CMC, Clinical, Pharmacovigilance, and Medical Writing
• Act as a point of contact for Health Authorities, including handling deficiency letters and regulatory queries
• Track submission status, approvals, regulatory commitments, and timelines
• Maintain regulatory databases, trackers, and documentation in a compliant manner
• Support regulatory audits, inspections, and internal assessments as required

Experience
• 4 to 6 years of hands-on experience in Regulatory Affairs within Pharma or Life Sciences
• Strong exposure to CTD and eCTD dossier compilation and publishing
• Experience in regulatory submissions, lifecycle management, and health authority communication

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

Skills
• Strong understanding of global regulatory requirements (US, EU, and ROW)
• Hands-on experience with eCTD publishing tools and submission processes
• Excellent documentation, coordination, and communication skills
• Ability to manage multiple submissions independently
• High attention to detail with a compliance-focused approach
• Ability to work effectively in a fast-paced, service-oriented environment

About the Company
Medifodil Smart Pharma Solutions is a growing pharmaceutical services organization providing regulatory and compliance support to global life sciences companies. The company focuses on delivering high-quality, efficient, and compliant regulatory solutions across multiple international markets.