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 prospects.

Stay informed about industry trends and regulatory developments.

CTD & Country Specific Dossiers Compilation

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