About the role
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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