RA Executive Dossier Compilation

Roles & Responsibilities:

• Compile and review CTD & ACTD dossiers for product registrations, renewals, and variations
• Ensure accuracy, consistency, and completeness of regulatory documents before submission
• Coordinate with QA, QC, R&D, Production, and Packaging teams to collect technical data
• Prepare and submit responses to regulatory queries and deficiency letters within timelines
• Manage version control and lifecycle management of regulatory documents
• Support post-approval changes, renewals, amendments, and variations
• Assist during audits, inspections, and regulatory assessments

Qualification:

• Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm)

Experience:

• 2-4 years of experience in Regulatory Affairs
• Dossier compilation experience (CTD / ACTD) mandatory
• Candidates from merchant pharmaceutical companies preferred

Skills:

• Strong knowledge of CTD / ACTD formats and global regulatory guidelines
• Excellent documentation, formatting, and proofreading skills
• Strong coordination and time management abilities
• High attention to detail and compliance-focused mindset

About the Company:

Infocus Remedies Pvt. Ltd., a group company of Saifen Drugs India Pvt. Ltd., is engaged in pharmaceutical manufacturing and global regulatory operations, offering strong exposure to domestic and international regulatory submissions.