Assistant Manager

2 weeks ago


Bengaluru, India Syngene Full time

Core Purpose of the Role:  

Responsible for National Regulatory Affairs function in Syngene International Limited, Semicon park Approvals related to import, development, Clinical Trial approvals and bioanalytical testing import licenses, manufacture, storage and export of drug substance and drug product (human), as well as other associated approvals, namely: recombinant, narcotics, and any other approvals as relevant.

Primary Responsibilities:

Providing consultation to the stakeholders and clients regarding national regulatory aspects, as and when required. implementing and maintaining process, procedures, and trackers that are essential for national regulatory support function performance in the organization Identifying the regulatory requirements Interacting with the regulators and coordinating their inspections/ visits to Syngene. Coordinating with stakeholders and ensuring successful inspection at Syngene Providing time to time update to the stakeholders on the licences and participating in teleconferences/ discussions with stakeholders / clients as required To train / bring awareness to stakeholders with respect to regulatory requirements. To train regulatory team members in relevant national regulatory support activities Planning and execution of the regulatory activities with regulators and for internal stake holder

Secondary Responsibilities:  

Support Business Development and the Management in the Request for Proposals and any business queries related to National Regulatory requirement Supporting Program management in planning and tracking the National regulatory support activity

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