Syngene International Limited
Location
Bangalore | India
Job description
Education: B. Pharm
Experience: 9-12 years
Demonstrated Capability:
· Analysis of rules and regulations of drugs and its accurate application in regulatory function
· Maintaining regulatory trackers and alert mechanism
· Understating of regulatory queries and suggest appropriate response to the regulator
. Strategic Planning & Execution Corporate Liaison and Affairs.
· Regulatory Compliance (Inspection, Approvals & Licenses).
· Client Relationship Management Team building and leadership.
Role Accountabilities:
Responsible for assisting in National Regulatory Affairs function in Syngene International Limited, Biocon Park, MN Park Hyderabad & MSEZ Mangalore facilities for:
a) Approvals related to import, development, manufacture, storage and export of drug substance and drug product (human and animal), as well as,
b) Other associated approvals, namely: biosafety, recombinant, narcotics, atomic energy related, agriculture related, animal husbandry related, food related, and any other approvals as relevant.
· 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 licenses 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 holders.
· 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.
Job tags
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