Torrent Pharma UK Ltd

Compliance

• Support eCTD submissions for Torrent Pharma UK and the Group
• Prepare and submit marketing authorisation variations and renewals to agreed deadlines
• Carry out product information compliance activities in line with MHRA requirements, including monthly SmPC checks
• Compile administrative documentation for CTD dossiers and liaise with regulatory authorities to support submissions and approvals
• Review, approve and release packaging and labelling documentation
• Coordinate artwork development and updates with designers and manufacturing sites, and maintain labelling systems
• Coordinate pharmacovigilance activities and maintain the PV tracker
• Provide source information for PSURs, RMPs and renewals
• Coordinate regulatory submissions and responses to requests for information
• Work with the outsourced PV provider on new marketing authorisation applications, safety documentation and SmPC/PIL updates
• Maintain accurate regulatory files, databases, submission histories and marketing authorisation records
• Contribute to the preparation and review of regulatory procedures and cross-functional processes
• Identify regulatory compliance gaps, support impact assessments and corrective actions, and collaborate with internal teams and contract manufacturing partners

Explore Regulatory Affairs – Pharmacovigilance Officer at Torrent Pharma UK Ltd. Review requirements and application details.