GSK Life Science Regulatory Specialist Recruitment – Apply Online
GSK Life Science Regulatory Specialist Recruitment – Apply Online. GlaxoSmithKline Regulatory Specialist, Labelling Coordination-Senior job opportunities. QC Life Science Careers at GSK. GlaxoSmithKline GSK Bengaluru vacancies for Regulatory Specialist. Check out all of the details below:
Name of the Position: Regulatory Specialist, Labelling Coordination-Senior
Type: Full-Time
Locations: Bangalore R&D India
Categories: Regulatory
Req ID: 250350
Job Description:
- Efficient coordination and also communication of labelling documentation such as Global Product Info (PI), International PI, Country Labelling Differences, Responses to Agency Labelling Questions, EU PI (including translations) and United States PI
- Providing support to GRA Labelling staff to guarantee the quality and also consistency of labelling document content consisting of editing Global/regional/country PI, generation of Country Labelling Differences and also 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 accepted Global and regional/country PI
- Efficient communication with GSK staff (including Global Regulatory Affairs, Global safety as well as medical as well as Local Operating Companies) to collate, compile and also 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 procedures and also systems according to GSK policies and also procedures
- Supporting other labelling functions as well as participation in other projects and also activities as needed, such as contributing to the implementation of changes to procedures within GRA Labelling.
Why you?
Basic Qualifications:
We are looking for professionals with these required abilities to achieve our objectives:
- Bachelor’s degree in Life Sciences or comparable regulatory experience (consult manager on equal regulatory experience).
- 4-6+ years relevant experience (in pharmaceutical industry, life sciences research 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 also database management, outstanding organization and time management abilities.
- Superb written and also verbal communication skills and also capacity to present information in a clear as well as concise manner.
- Capacity to think flexibly in order to meet continuously shifting priorities and timelines.
- Broad understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- An understanding of labelling (e.g. with direct or indirect exposure to the management of labelling documents/submissions/data).
Why GSK?
Our values and also expectations are at the heart of everything we do and form an important part of our culture.
These consist of Patient focus, Transparency, Respect, Integrity in addition to Courage, Accountability, Development, and Teamwork. As GSK focuses on our values as well as expectations and a culture of innovation, performance, and depend on, the successful applicant will certainly demonstrate the following capacities:.
- Operating at pace as well as agile decision-making– making use of evidence and also applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, concentrating on what matters, execution.
- Continuously looking for opportunities to learn, develop skills and share learning.
- Sustaining energy and also well-being.
- Building strong relationships and also collaboration, honest as well as open conversations.
- Budgeting and cost-consciousness.
Apply Online
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