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 Product Quality Review - Promote regulatory intelligence in both local and regional initiatives - Develop regulatory strategies, prepare regulatory applications, and support maintenance activities within relevant therapy areas - Execution of regulatory strategies (local and regional) that are in line with the business plan - Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met - Ensure adherence to timelines and quality set parameters R - eview of formulation, generation of ingredient list, and claims per set standards - Compilation and review of labeling components per SOP Deliverables: - CMC modules 2 and 3 - Management of the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approval - Review of CMC modules - Execution of regulatory strategies (local and regional) that are in line with the business plan - Compilation of PQR as per SOP – Summary report of variations submitted as per the specified period. - Review of formulation, generation of ingredient list, and claims per set standards - Compilation and review of labeling components per SOP Experience/Qualifications: - Bachelor’s/Master’s degree in Life Science/Pharma - Six to eight years of relevant work experience - RAPS certification is desirable