Regulatory Specialist, Global Labelling
- Bangalore, India
Site Name: India - Karnataka - Bengaluru
Posted Date: Dec 5 2019
Are you looking for an opportunity to support a regulatory environment where you will be a part of Global labelling initiatives and Timely maintenance of Global and regional/country Product Information (PI), including information for healthcare professionals and patients. Provides expertise and support to LOCs with respect to Global PI processes and responses to Regulatory Agency questions about PI.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Efficient management of updates to Global PI including: leading the functional experts to generate content, authoring identified sections of the Global PI, presentation of items at Global Labelling Committee, and ensuring compliance with associated timelines.
- Efficient maintenance of country/regional labelling in compliance with GSK Labelling processes and external requirements such as management of the International PI document, US PI and EU PI (for Centralised, Mutual Recognition and Decentralised procedure submissions)
- Act as subject matter expert in GSK Global Labelling process and/or US/EU product information requirements.
- Support the LOCs in the implementation of Global PI text into country PI.
- Author responses to Regulatory Agency questions about PI.
- Authoring documentation to support the Global Labelling Committee Secretariat, as required.
- Effective planning, prioritization, communication and delivery of quality labelling documents according to company timelines and submission requirements.
- Train/coach others, as required.
- Participation in other projects and activities, such as leading implementation of changes to labelling processes.
We are looking for professionals with these required skills to achieve our goals:
- 7-9 years relevant experience (in Global labeling at pharmaceutical industry ).
- Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research or regulatory).
- Attention to detail, 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 and to independently provide solutions to issues.
- Well-developed understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- Well-developed understanding of labelling (e.g. significant experience in managing local labelling documents/submissions and/or management of global labelling documents).
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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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