Lead-Regulatory Affairs CMC

Primary Responsibilities • Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval. • Responsible for writing CMC modules 2 & 3. • Exposure to EU & CIS region in Regulatory filings • 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, tender application, and whenever necessary. • Maintain regulatory work processes and tracking tools that improve performance levels and transparency. • Promote regulatory intelligence in both local and regional initiatives. • Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area. • Responsible for reviewing CMC modules. • Execution of regulatory strategies (local and regional) in line with business plan. • Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met. • Ensure to adherence to timelines and quality set parameters. • Review of Formulation, generation of ingredient list and Claims as per set standards. Qualification • Minimum B.S. Chemistry, Pharmacy or related scientific field • Experience in CMC regulatory affairs for pharmaceutical products. • Experience in Module 3, Module 2.3 and relevant Module 1 e-CTD documentation Apply tot his job Apply To this Job