Asst. Manager/Manager - RA

Job Summary

Position: Asst. Manager/Manager - RA

Location: Daman

Experience: 15 - 20 Years

Industries: Pharma

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 RD, QA, QC, Production and other departments for regulatory documentation.
• Handle regulatory submissions and approvals for new 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

Required Qualification

B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

Key Skills

• R&d
• Qa
• Qc