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Regulatory Affairs Labelling Strategy Specialist

1 month ago


London, Greater London, United Kingdom GlaxoSmithKline Full time

Seize the opportunity to excel in a global pharmaceutical company as a Regulatory Affairs Labelling Strategy Specialist.

About GSK

GSK is a leading biopharmaceutical company that unites science, technology, and talent to get ahead of disease together. Our mission is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.

Job Summary

We are seeking an experienced Regulatory Affairs Labelling Strategy Specialist to join our team in London. As a key member of our Global Regulatory Affairs (GRA) Labelling Strategy and Development department, you will play a critical role in ensuring the accuracy and consistency of labelling information for our medicines and vaccines worldwide.

The successful candidate will have a strong background in regulatory affairs, with experience in labelling strategy and development. You will work closely with cross-functional teams to develop and implement labelling strategies that meet regulatory requirements and ensure patient safety.

Key Responsibilities
  • Develop and implement labelling strategies for new and existing products, ensuring compliance with regulatory requirements and GSK's policies.
  • Collaborate with colleagues in Clinical, Safety, Regulatory, and other functions to ensure accurate and consistent labelling information.
  • Author responses to regulatory questions on labelling and prescribing information from Regulatory Authorities.
  • Manage documentation to support global and country/regional product information development and early maintenance.
  • Ensure GRA Labelling data is accurately maintained in Veeva vault.
Requirements

To be successful in this role, you will need:

  • A degree in Life Sciences or Pharmacy.
  • Relevant experience in labelling strategy and development, regulatory affairs, medical affairs, clinical research, pharmacovigilance, or therapeutic area experience.
  • A track record of authoring clear scientific labelling text for health professionals and patients.
  • Fluency in English.
  • Strong communication and collaboration skills.
  • A focus on improving performance and excellence in all tasks.
What We Offer

GSK offers a competitive salary range of £60,000 - £80,000 per annum, depending on experience, plus a comprehensive benefits package including pension, life assurance, and flexible working arrangements.

We value diversity and inclusion at GSK and welcome applications from candidates with disabilities. If you require any reasonable adjustments during the recruitment process, please let us know.