Senior Associate 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


• Review 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


• Four to six years of relevant work experience


• RAPS certification is desirable