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Regulatory Affairs Manager

2 months ago

London, Greater London, United Kingdom GSK Full time
Job Description

Job Title: Compliance Manager

Job Summary:

We are seeking a highly skilled Compliance Manager to join our team at GSK. As a key member of our regulatory affairs team, you will be responsible for ensuring the development and execution of regional regulatory strategies that align with our Medicines Development Strategy.

Key Responsibilities:

  • Develop and implement regional regulatory strategies that meet internal GSK process and policy requirements, as well as regional regulatory requirements.
  • Work closely with local and regional commercial teams to secure best possible labeling commensurate with available data.
  • Lead interactions with local and regional regulatory authorities.
  • Ensure regulatory strategies deliver needs of local region(s), taking into account needs of other regions globally.
  • Implement regional strategies in support of global projects.
  • Lead regulatory interactions and review processes in local region.
  • Ensure compliance with regional requirements at all stages of product life cycle.

Requirements:

  • Bachelor's degree.
  • Experience in Regulatory Affairs within a pharmaceutical organization.
  • Experience working with Global Health Authorities and submissions for Pharmaceutical products.
  • PhD or Masters' degree in life sciences or pharmacy.
  • Strong technical knowledge required to assess regulatory compliance of products.
  • Ability to interact with regulatory officials and support advocacy initiatives.

About GSK:

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 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). As an Equal Opportunity Employer, we are open to all talent.

We believe in an agile working culture for all our roles.