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