India - Karnataka - Bangalore, India - Maharashtra - Worli Mumbai
Aug 3 2020
(On Contract) – Consultant NCE Submission Coordinator
1-2 years of experience in EU or emerging market regulatory filing
With management oversight, accountable to deliver to Project Lead or GRL/ Regional Rep/ C&EP lead for delivery of assigned submissions to agreed timeframes and appropriate content
Will require to have technical expertise for EU and EMAP markets guidelines
Beginning to understand internal/external CMC Regulatory environment
Begin to build organisational networks.
Regular communication with line manager or technical lead to help identify any technical issues with business impact.
Manages routine project assignments with some level of support from manager
With management oversight, ensures quality of both own and submission team work and compliance with regulatory guidelines and process as they apply to the role.
Works with staff from other functions and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidance’s, researching topics and resolving issues.
May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
May be responsible for the life cycle maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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