1mo ago

Senior Strategist - Regulatory Affairs (CMC)

City, State/County - Country senior

Legal & ComplianceOtherRegulatoryRegulatory Affairs

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Key Responsibilities

Manage the preparation and submission of new product registrations, post approval submission,

Technical Tools

Legal & ComplianceOtherRegulatoryRegulatory Affairs

~1 min read

→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

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