Job Description

Job Purpose : Provide expert advice and support to labelling stakeholders with respect to global and local Product Information (PI) processes. Timely maintain the global and local labelling documents (including information for healthcare professionals and patients) and data in regulatory systems in accordance with defined standards and processes.Key Responsibilities :

• Maintain the Global Datasheet (GDS) in conjunction with functional experts.
• Maintain the EU PI (CP/MRP/DCP), International Product Information (IPI), Vx WHO and PAHO PI and Medical Device product labels. Ensure compliance with global PI and submit country labelling difference if any.
• Manage the PI for products in conjunction with a third party.
• Coordinate the readability testing of the EU Package Leaflet when applicable.
• Lead the discussion at Labelling Review Team (LRT) around the proposed wording for the GDS and centrally managed PIs (when applicable) and seek agreement with all stakeholders involved.
• Author and coordinate the supportive packages for submission to the Global Labelling Committee (GLC). Author GLC meeting minutes (if applicable).
• Support the Local Operating Companies (LOC):

• in the implementation of Global PI text into country PI.
• in authoring and coordinating responses to labelling questions from regulatory agencies.
• in evaluating LOC submission delay request and facilitating its approval if required.
• Demonstrate expertise in GSK Global Labelling processes.
• Effectively plan, prioritise, communicate and deliver quality labelling documents according to timelines and submission requirements.
• Participate in other projects and activities, implement the changes to labelling processes, new regulations and guidelines. Proactively identify the areas for improvements/efficiencies in existing labelling processes.
• Take accountability for relevant sections of the periodic aggregate reports like PBRER, ACO, Addendum Reports, DSUR, etc.
• Member of the Regulatory Matrix Team (RMT) and the Safety Review Team (SRT) as appropriate.
• May represent Global Labelling in Product Investigation Review Committee (PIRC) and internal audits.
• May represent GSK Global Labelling in

• inspections or meetings with regulatory authorities.
• external events (conferences/seminars, etc.).
• Train/coach others, as required.

Education Requirements :Level of education: Bachelors / Masters degreeArea of specialization: Life Sciences or Pharmacology or equivalentWhy is it required?The ability to interact confidently with highly educated staff, customers and partners in a complex technical environment is essential to this role.The ability to understand the scientific content of labelling documentsJob Related Experience :7 years relevant experience (in pharmaceutical industry or regulatory). * Understanding of the pharmaceutical industry, drug development environment and regulatory processes.

• Preferred experience in labelling or regulatory affairs.

Why is this level of experience required?Must be able to lead cross functional team and work with individuals at all levels of the business to consistently deliver quality labelling documents in a highly regulated environment within a global organization.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in gsk.com, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

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