Regulatory Affairs- CMC Expert
Imedglobal Solutions India Private Limited
2 - 6 years
Bengaluru, Hyderabad
Primary Responsibilities:
* Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval.
* Responsible for writing CMC modules - 2 & 3.
* Exposure to EU & 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, tender application, and whenever necessary.
* Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
* Promote regulatory intelligence in both local and regional initiatives.
* Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
* Responsible for reviewing CMC modules.
* Execution of regulatory strategies (local and regional) in line with business plan.
* Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
* Ensure to adherence to timelines and quality set parameters.
* Review of Formulation, generation of ingredient list and Claims as per set standards.
* Compilation and review of labeling components as per SOP.
2 to 3 Years 
Salary not disclosed 
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