Regulatory Affairs Associate

📋 Description

• Regulatory impact assessments for change controls and regulatory implications for changes in
• Maintain regulatory change records within Veeva RIMS and support post-approval activities.
• Develop regulatory strategies for post-approval changes across European markets.
• Review and author Module 3 sections of CTD dossiers for medicinal products.
• Ensure CMC documentation is accurate and aligned with regulatory expectations.
• Support dossier lifecycle management across multiple European markets.

🎯 Requirements

• 3+ years in regulatory affairs, especially post-approval activities for medicinal products.
• Experience with European procedures: CP, MRP, DCP, and National procedures.
• Practical knowledge of post-approval lifecycle management and MA maintenance in Europe.
• Experience assessing regulatory impacts of manufacturing, quality, labeling changes.
• Strong CMC knowledge; experience reviewing or authoring Module 3 of CTD dossiers.
• Familiarity with regulatory information systems, especially Veeva RIMS.

🎁 Benefits

• Opportunity to contribute to regulatory lifecycle of medicinal products.
• Exposure to European regulatory procedures and post-approval management.
• Develop expertise in CMC, CTD, regulatory impact assessments, and RIMS.
• Collaboration with multidisciplinary, international teams.
• Remote-work flexibility for eligible India-based locations.
• Professional development and growth in regulatory affairs.