Regulatory Associate Manager - Global Labelling

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 / Master’s degree

Area of specialization: Life Sciences or Pharmacology or equivalent

Why 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 documents

Job 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, it’s 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.

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