Analyst - Regulatory Affairs

Roles & Responsibilities
• Compile and submit Drug Master Files (DMFs) to various regulatory agencies
• Prepare dossiers as per requirements of USFDA, EDQM, ASMF, Health Canada, WHO, and other regulatory authorities
• Prepare and submit responses to queries received from customers and regulatory agencies
• Support preparation of DMF amendments, CEP revisions, and lifecycle management updates
• Evaluate change controls and assess regulatory impact
• Ensure PDF properties and formatting compliance for uploading dossiers into pharma-ready eCTD software
• Convert documents into XML backbone and manage submission through ESG Gateway (USFDA) and CESP portal (EU)
• Coordinate with internal stakeholders for timely submission and project execution
• Support continuous improvement of departmental procedures and compliance practices
• Contribute to overall Regulatory Affairs operations while promoting teamwork, integrity, and compliance culture

Qualification
• Master’s degree or equivalent in Pharmaceutical Sciences, Chemistry, Pharmacy, or Life Sciences
• Master's in Pharmacy

Experience
• 3+ years of experience in Regulatory Affairs with focus on API DMF filings
• Experience working in a generic pharmaceutical company
• Hands-on experience with eCTD submission software for US, EU, and Canada markets

Skills
• Strong knowledge of ICH Guidelines, DMF, EDMF, GMP, GLP, and GCP principles
• Good understanding of regulatory submission requirements for global markets
• Experience in handling regulatory queries and lifecycle management activities
• Strong documentation and dossier compilation skills
• Effective interpersonal and stakeholder coordination abilities
• Attention to detail and strong compliance orientation
• Ability to manage multiple projects within defined timelines

About the Organization
Granules India Limited is a vertically integrated pharmaceutical company specializing in the manufacturing of APIs, pharmaceutical formulation intermediates, and finished dosages. With a strong global presence and regulatory-compliant manufacturing facilities, including its Gagillapur Plant in Hyderabad, Granules India Limited is committed to quality, innovation, and delivering affordable medicines worldwide.