Must Have Knowledge of CTD & Country Specific Dossiers Compilation, Site Master Files (SMF) & Stability Study Reports Regulatory Submissions:
Prepare and submit regulatory documentation, including applications, amendments, and notifications to health authorities.
Ensure compliance with regulatory requirements for product registration, labeling, and advertising.
Regulatory Compliance:
Monitor and track regulatory changes and updates to ensure compliance.
Conduct regulatory impact assessments and provide guidance to cross-functional teams.
Documentation Management:
Maintain accurate and up-to-date regulatory records and documentation.
Organize and manage regulatory files for easy access and retrieval.
Regulatory Affairs Projects:
Support regulatory projects, such as product launches, lifecycle management, and post-market surveillance.
Coordinate with cross-functional teams to ensure timely completion of regulatory tasks.
Regulatory Intelligence:
Conduct regulatory research and analysis to identify potential risks and opportunities.
Stay informed about industry trends and regulatory developments.

CTD & Country Specific Dossiers Compilation

📌 Regulatory Affairs Sr Executive/ Manager (New Delhi)
🏢 Pharmeda Healthcare
📍 New Delhi