Assistant manager - Regulatory Affairs

We are looking for an Assistant Manager - Regulatory Affairs to join our Regulatory Affairs team. The candidate will be responsible for preparation and review of registration dossiers and variations according to EU regulatory requirements. The role is based in Mumbai/Hyderabad and requires at least 8 years of work experience in international regulatory affairs from the Pharma industry.

Requirements

• Preparation and review of registration dossiers and variations according to EU regulatory requirements
• Identification and classification of changes as per EU regulatory variation guidance
• Preparation of response to regulatory deficiencies letters according to EU regulatory requirements
• Collaboration with other departments and partners
• Maintenance of lists/documents/records
• Keeping Orion internal regulatory system up to date and accurate
• Achievement of responsibilities within agreed timescales
• Participation in the development of regulatory skills within the regulatory team

Benefits

• Hybrid work policy
• Flexible working environment
• Good work-life balance
• Clear and transparent processes
• Responsible supervisors