- Lead the Regulatory Affairs function and manage regulatory submissions for domestic and international markets.
- Prepare, review and submit CTD/eCTD dossiers, variations, renewals and regulatory responses.
- Coordinate with RD, QA, QC, Production and other departments for regulatory documentation.
- Handle regulatory submissions and approvals for current products, existing products and post-approval changes.
- Review product dossiers, technical documents, specifications, stability data and compliance documents.
- Manage regulatory queries and ensure timely responses to health authorities.
- Monitor changes in regulatory guidelines and requirements and ensure compliance.
- Support regulatory audits and inspections and coordinate responses to observations.
- Maintain regulatory databases, submission trackers and approval records.
- Lead and mentor the RA team and ensure timely completion of regulatory activities.
Required Skills
- Strong knowledge of Pharma Regulatory Affairs CTD/eCTD
- Experience in US/EU/ROW or regulated markets
- Expertise in regulatory submissions, variations renewals
- Strong knowledge of GMP and regulatory guidelines
- Excellent documentation and communication skills
- Strong coordination, leadership and problem-solving abilities
- Experience with ERP/eQMS and regulatory submission systems will be an added advantage