SAIN MEDICAMENTS PVT. LTD
Website:
saingroup.com
Job details:
Regulatory Affairs - Associate (Fresher )
Job Roles & Responsibilities
Documentation & Dossier Preparation
- Assisting in preparation and compilation of regulatory dossiers such as CTD/eCTD.
- Collecting documents from departments like QA, QC, Production, R&D, and Packaging.
- Reviewing documents for completeness and accuracy before submission.
- Maintaining product files, licenses, and regulatory records.
Regulatory Submissions
- Supporting product registration submissions to regulatory authorities like:
- CDSCO
- WHO
- Assisting in renewal, variation, and amendment applications.
- Tracking submission timelines and approval status.
Compliance Activities
- Ensuring products comply with current regulatory guidelines and GMP requirements.
- Assisting during audits and inspections.
- Supporting implementation of regulatory updates and changes.
Labeling & Artwork Review
- Checking packaging materials, labels, inserts, and artworks for regulatory compliance.
- Verifying product claims, batch details, warnings, and mandatory information.
Qualifications:
- M.Pharm or B.Pharm
- PG Diploma in Regulatory Affairs
- Certification in International Regulatory Affairs
Click on Apply to know more.