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Senior Strategist - Regulatory Affairs, CMC at ClinChoice | Swiftcruit
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
