Responsibilities:
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 R&D;, 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:
Robust 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
Robust coordination, leadership and problem-solving abilities
Experience with ERP/eQMS and regulatory submission systems will be an added advantage