Job Description

To ensure API regulatory activities are as per stipulated time schedule and timely readiness of API regulatory documents / DMFs for new submissions / updates.


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To provide the necessary regulatory support/ advice/ guidance to the concerned API Manufacturing sites/ R & T Unit.


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To assure the quality of DMF, its submission and maintenance of submitted DMFs and updation on DMFs taking into consideration company Intermediates business.


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To provide technical inputs to Section Heads for APIs/Key for regulatory adequacy


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To co- ordinate and collaborate with QA/ QC/ Production/ Development department of API/CDMO/Crop Business.


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Adequate deficiency responses within stipulated timelines.


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Compliance to KPIs of global regulatory department


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Responsible for implementation, strengthening, maintenance of Quality Management System in accordance with ISO & Regulatory / cGMP guidelines (ICH Q7) at R&T Pune


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Responsible for approval of GMP documents viz. batch record, Certificate of Analysis, Quality Technical Agreements, Site Quality Manual, Standard Operating procedures, Site Master file, Validation master plan and QMS documents etc. Ensure error free documentation activities at R&T Pune Site.


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Support to development team (R&T) process and analytical for smooth functioning of scale up activities technology transfer to meet the business expectations.