Job Purpose :

- Timely update, management and communication of quality regional/country Product Information (PI)/labelling and supporting documentation. Holds line management responsibilities for direct reports. 

- Leads and manages the Regulatory Country Labelling team to ensure timely maintenance of regional/country Product Information (PI) for GSKs Pharma and Vaccines product portfolio. Effective coordination, communication and maintenance of regional/country labelling documents and data in regulatory systems in accordance with defined standards and processes.

- This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following.

- Recruit and lead a team of labelling staff ensuring appropriate knowledge and competency is maintained to support workload and sustain an efficient and motivating working environment.

- Support country/regional labelling for Pharma and Vaccines in compliance with GSK Labelling processes and external requirements. 

- You will deliver the following aspects of labelling (either directly or via your direct reports):

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 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 leading the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements.

- Effective planning, prioritization, communication and delivery of quality labelling documents according to company timelines and submission requirements.

- Contribute to work forecasting/resource management activities

- Participation in other projects and activities, such as identifying areas for improvements/efficiencies and leading implementation of changes to labelling processes, identify risks to quality and/or timely completion of projects, resolving any issues and escalating items to be resolved at a higher management level

- Build and maintain quality relations with your internal and external stakeholders.

- Work closely with your peers, functional manager and line manager to drive standardization across the business.

- We are looking for an experience individual and if you have these skills, we would like to speak to you.

- 8+ years relevant global regulatory experience within a regulated or quality-critical environment & leading the functional experts to generate content, which includes 2+ years of people management experience

- 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.

- Ability to lead problem solving and negotiate solutions to complex labeling 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).

- Previous line management experience for a team of more than 4 people that has successfully delivered regulatory outputs to time and quality over a sustained period.

- Experience of maintenance of labelling documents in multiple countries/regions including knowledge of label document content, process and associated regulatory agency labelling requirements. 

Experience of more than 1 of the following regions/countries:

EU PI annexes (including EU CP/MRP/DCP procedures)

US PIs

Canadian Monographs

ROW PIs

Why GSK?

Our values and expectations are 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. 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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