- Preparation of Regulatory Dossiers: Prepare regulatory dossiers for various countries by coordinating and collecting data/documents from various departments in the plant and reviewing them for compliance before dossier preparation.
- Vendor and Manufacturer Coordination: Contact API vendors and manufacturers for DMFs/APIMFs/Tech packs, review the documents, and ensure compliance with CTD requirements.
- Artwork Development Coordination: Coordinate with graphic designers for labels and packaging material artwork development.
- Sample Planning for Registration: Plan for registration samples in coordination with concerned departments and ensure readiness as per the submission plan.
- Handling Queries: Handle queries received from clients and drug authorities, ensuring the required information/documents are provided within stipulated timelines.
Knowledge and Skills Required:
- Regulations and Compliance: Explain regulations, policies, or procedures and ensure adequate compliance.
- Technical Review: Provide correct and accurate technical review of data or reports.
- Documentation Management: Oversee the planning, coordination, and management of regulatory documentation activities.
- Regulatory Guidelines Interpretation: Examine, identify, and interpret relevant regulatory guidelines.
- Impact Analysis: Analyze and evaluate laws and regulations to determine the impact on company activities.
- Regulatory Documentation: Compile and oversee the maintenance of regulatory documentation databases or systems.
- Submission Preparation: Coordinate efforts related to the preparation of regulatory documents or submissions.
- Communication with Regulatory Agencies: Develop and maintain healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review.
