Gepach International is an export oriented specialty pharmaceutical company engaged in the development, manufacturing and marketing of quality finished dosages in major therapeutic segments.
Post : Regulatory Affairs - Europe Market
Experience : Executive : 2-5 years, Manager : 6-10 years
Location : Pithampur (Indore)
Key Responsibilities
• Prepare, review and submit CTD/eCTD dossiers for Europe (EU) Market.
• Manage product registrations, renewals, variations and lifecycle activities.
• Review SmPC, PIL, artworks, labels and other regulatory documents.
• Liaise with EMA. international clients and regulatory authorities.
• Ensure compliance with EU guidelines and regulatory requirements.
• Coordinate with QA, QC, Production, R&D and Supply Chain teams.
• Respond to regulatory queries within timelines.
Candidate Profile
• Experience in Regulatory Affairs for Europe (EU) Market.
• Hands-on experience in CTD/eCTD dossier preparation and submissions.
• Good understanding of EMA guidelines and EU regulatory requirements.
• Strong documentation, communication and coordination skills.
• Pharmaceutical formulation background preferred.
INTERESTED CANDIDATES CAN SHARE THEIR UPDATED CV AT preetihr@gepach.com
GEPACH INTERNATIONAL
Pithampur Plant, Indore, Madhya Pradesh, India
Last Date : 31st July 2026
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Delhi Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
