Regulatory Affairs -

 

1. Regulatory Strategy and Planning: Developing and implementing strategies to meet regulatory requirements and address issues during drug development.

 

2. Dossier Preparation and Submission: Preparing and submitting dossiers in formats like CTD/eCTD, and coordinating with health authorities.

 

3. Clinical Trial Compliance: Ensuring that clinical trials follow specific country regulations, which often involves designing strategies for appropriate documentation.

 

4. Market Access: Streamlining the approval process and managing product classification and compliance mapping for market entry.

 

5. Post-Approval Management: Handling all lifecycle activities, including renewals, variations, labeling updates, and artwork management.

 

6. Health Authority Liaison: Acting as a crucial link between the organization and health authorities, and coordinating with them for various submissions and queries.

 

7. Pharmacovigilance: Providing support for safety monitoring and compliance with mandatory pharmacovigilance requirements.

 

8. Gap Analysis and Remediation: Identifying gaps in documentation and creating plans to fix them to meet regulatory standards.