Executive - Regulatory Affairs

Roles & Responsibilities
• Handle regulatory submissions for new products, renewals, variations, and lifecycle management for MENA markets
• Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions
• Review development reports, scale-up reports, specifications, stability protocols, and artworks prior to exhibit batch initiation
• Prepare and review responses to regulatory deficiencies to enable product approvals
• Manage lifecycle variations including API vendor changes, ROS/test parameter updates, drug formulation (DF) site changes, and product harmonization
• Prepare, review, and circulate approval packages along with product history sheets to stakeholders
• Update approval documentation based on regulatory queries and variations
• Ensure proper repository and maintenance of comprehensive product information in central systems
• Assess regulatory filing impact of variations and change controls

Qualification
• M.Sc or M.Pharm (Master of Pharmacy)

Experience
• 1–4 years of experience in Regulatory Affairs
• Experience in CMC documentation, variations, renewals, and lifecycle management
• Exposure to MENA or international markets preferred

Skills
• Strong knowledge of CMC dossier preparation and regulatory submission processes
• Understanding of lifecycle management and variation filing requirements
• Familiarity with regulatory compliance and documentation control
• Good analytical and documentation review skills
• Strong communication and stakeholder coordination abilities
• Detail-oriented with strong organizational skills

About the Organization
Sun Pharmaceutical Industries Ltd. is one of the world’s leading specialty generic pharmaceutical companies, committed to delivering high-quality, affordable medicines globally while fostering innovation, regulatory excellence, and continuous professional growth.