GSK Regulatory Specialist Recruitment 2021 – Apply Online
GSK announces regulatory specialist job opening 2021. Pharmacy job opening 2021, Pharma job opening 2021. Pharma job 2021. GSK is one of the world’s foremost pharmaceutical and healthcare companies and we are proud to be leading a healthcare revolution. Join us and help empower GSK. Check out all the details on the same below:
Job Title: Regulatory Specialist, Country Labelling – Level 1
Site Name: India – Karnataka – Bengaluru
This role will provide YOU with the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following.
- Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.
- Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.
Provide support to global and local GRA team members through preparation of other - labelling documents as required Complete quality and consistency checks of labelling document content.
- Efficiently coordinate and manage labelling documentation and data in regulatory systems.
- Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
- Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to the author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.
- Support other regulatory functions and participate in other projects and activities as needed, such as contributing to the implementation of changes to labelling processes and evaluation of new agency labelling requirements.
- For some roles, may be required to perform translation of labelling text into identified languages.
- May become an SME in the country/regional labelling content and process.
- We are looking for an experienced individual and if you have these skills, we would like to speak to you.
Eligibility Criteria & Experience:
- 1-3 years of relevant experience (in the pharmaceutical industry research or regulatory).
- Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research, pharmacy, safety or regulatory).
- Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple tasks.
- Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Broad understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- An understanding of labelling (e.g. through direct or indirect exposure to the management of labelling documents/submissions/data).
- Experience in updating and managing Regional/Country Labeling documents.
Proficient with computer software applications - Familiar with medical terminology
- Ability to negotiate solutions to moderate labelling issues and proactively identify improvements for labelling processes
- Knowledge of labelling regulations/requirements in 1 or more regions.
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