Job title: SENIOR EXECUTIVE

Company: Biocon

Job description: Department Details

Role is based out of global RA

Role Summary

The Global Regulatory Affairs (GRA) at Biocon consists pool of talented individuals who are the interface between the company and the regulatory agencies across the globe. Within the company, GRA group plays vital role in carving robust regulatory strategy built on strong scientific, technical and regulatory framework. The GRA group embraces individuals with hands on experience on process and product development; analytical sciences; quality management systems; regulatory writing and procedures, leading to successful global submissions and approvals.

Key Responsibilities

Dossier compilation – Coordinate with CFTs and compile dossier sections for product registrations & GMP applications as per the agreed regulatory strategy in MoW markets

LCM and renewals – Coordinate with CFTs and compile dossier sections for post approval changes, annual updates and renewals as per the agreed regulatory strategy in MoW markets

Responsible for maintenance of product lifecycle including deviations and change controls

Responsible for preparation, archival and maintenance of Core dossier sections and source documents.

Collection, archival and internal notification to all the stakeholders with respect to dossier, PAC, renewals, variation approvals

Responsible for cross functional regulatory support by providing regulatory documents eg. Participation for tenders

Educational Qualifications

Required Education Qualification: M.Pharma
Required Experience: 4 – 7 years

Expected salary:

Location: India

Job date: Fri, 29 Apr 2022 06:20:02 GMT

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