Regulatory Compliance
- Ensure compliance with applicable regulatory guidelines, laws, and industry standards.
- Monitor and interpret regulatory changes and communicate their impact to relevant departments.
- Support implementation of regulatory policies and procedures within the organization.
Product Registration & Submissions
- Prepare, review, and submit regulatory dossiers, applications, and registration documents.
- Coordinate product registrations, renewals, amendments, and variations with regulatory authorities.
- Maintain product licenses and regulatory approvals in accordance with statutory requirements.
Documentation Management
- Compile and maintain regulatory documentation, technical files, product dossiers, and compliance records.
- Review product labels, packaging artwork, promotional materials, and technical documents for regulatory compliance.
- Ensure proper document control and record retention practices.
Regulatory Coordination
- Liaise with government authorities, certification bodies, and external consultants.
- Coordinate with R&D, Quality Assurance, Manufacturing, Marketing, and Supply Chain teams regarding regulatory requirements.
- Support responses to regulatory queries and deficiency letters.
Audit & Inspection Support
- Assist during regulatory inspections, audits, and compliance reviews.
- Prepare required documentation and support corrective and preventive actions (CAPA) arising from audits.
Product Lifecycle Management
- Support new product launches from a regulatory perspective.
- Manage post-approval changes, product renewals, and regulatory updates.
- Track submission timelines and ensure timely regulatory approvals.
Pay: ₹30,000.00 - ₹40,000.00 per month
Work Location: In person
