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Healthcare
GSK Hiring For Consultant – Regulatory Specialist CMC Renewals Bengaluru, Karnataka Full Time
Site Name: India – Karnataka – Bangalore
Posted Date: Jul 21 2020
Posted Date: Jul 21 2020
Internal:
Key Responsibilities:–
With minimal input from manager,executes agreed dossier strategy.Manages multiple project assignments (e.g., Variations
Communicates with line manager to identify issues that have business impact.
May have dossier review responsibilities for peers and may identify improvement opportunities for Regulatory processes, policies and systems.
Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.
Understands internal/external Regulatory environment.
Actively builds an organizational network.
Communicates across GSK, with minimal input from manager regarding project and policy issues ensuring optimum position for GSK.
Job Related Experience:
4 – 7 years Experience in Regulatory Submission- Initial submissions, Variations, Renewals, for Europe(Mandatory), Rest Of the World & US region markets
Understanding and hands on experience on Product registration dossier/ CTD module
Hands on experience in different types of certificates, declarations and legalized documents – both QA & RA documents.
Experience in direct interactions with various on-site stake holders in GRPD departments
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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