Mirrai Careers

Senior Strategist - Regulatory Affairs (CMC)

ClinChoice

City, State/County - Country Posted 9d ago
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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

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