GSK Pharma Regulatory Specialist Post Vacancy – Apply Online
Pharma Regulatory Specialist. GSK invites postgraduate and undergraduate Pharma candidates for the post of Specialist. Interested and Eligible candidates in the field of the pharma may apply for this post. Check out all the details on the same below:
Location: Bangalore R&D, India
Category: Regulatory
Job Id: 250350
Job Title: Regulatory Specialist, Labelling Coordination-Senior
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in Pharmaceutical or equivalent regulatory experience (consult manager on equivalent regulatory experience)
- 4-6+ years relevant experience (in the pharmaceutical industry or regulatory).
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research or regulatory).
- Attention to detail, significant experience of document and database management, excellent organization and time management skills.
- Excellent written and verbal communication skills and ability to present information 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).
Job Description:
- Efficient coordination and communication of labelling documentation such as Global Product Information (PI), International PI, Country Labelling Differences, Responses to
- Agency Labelling Questions, EU PI (including translations) and US PI
- Providing support to GRA Labelling staff to ensure the quality and consistency of labelling document content including editing Global/regional/country PI, generation of
- Country Labelling Differences and periodic reports, and management of labelling artwork in accordance with relevant processes, templates and standards
- Storage of labelling documentation in regulatory systems including communication of approved Global and regional/country PI
- Efficient communication with GSK staff (including Global Regulatory Affairs, Global safety and medical and Local Operating Companies) to collate, compile and perform quality checks of labelling documents
- Management of GRA Labelling data in regulatory systems such as: PRION, GRACE, OSCAR, IMMS, eCTD Backbone, OPAL, HARMONY.
- Supporting GRA-labelling processes and systems in accordance with GSK policies and procedures
- Supporting other labelling functions and participation in other projects and activities as needed, such as contributing to the implementation of changes to processes within GRA Labelling.
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