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 approvalResponsible for reviewing and writing CMC modules 2 and 3Exposure to EU and CIS region in regulatory filings Herbal product development background Manage and coordinate product life cycle managementEnsure regulatory compliance with local regulatory requirementsFoster and maintain professional relationships with the health authoritiesProvide regulatory support including timely registration of new product and line extensions to support new product launches and tender applications when necessaryMaintain regulatory work processes and tracking tools that improve performance levels and transparencyExposure in writing of Product Quality ReviewPromote regulatory intelligence in both local and regional initiativesDevelop regulatory strategies, prepare regulatory applications, and support maintenance activities within relevant therapy areasExecution of regulatory strategies (local and regional) that are in line with the business planComplete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are metEnsure adherence to timelines and quality set parameters Review of formulation, generation of ingredient list, and claims per set standardsCompilation and review of labeling components per SOPDeliverables: CMC modules 2 and 3Management of the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approvalReview of CMC modulesExecution of regulatory strategies (local and regional) that are in line with the business planCompilation 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 standardsCompilation and review of labeling components per SOP

Experience/Qualifications: Bachelor's/Master's degree in Life Science/PharmaSix to eight years of relevant work experienceRAPS certification is desirable