Senior Strategist - Regulatory Affairs (CMC)

Responsibilities: Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval Responsible for reviewing and writing CMC modules 2 and 3 Exposure to EU and CIS region in regulatory filings Herbal product development background Manage and coordinate product life cycle management Ensure regulatory compliance with local regulatory requirements Foster and maintain professional relationships with the health authorities Provide regulatory support including timely registration of new product and line extensions to support new product launches and tender applications when necessary Maintain regulatory work processes and tracking tools that improve performance levels and transparency Exposure in writing of Produc…