Regulatory Affairs Director

1 month ago

Stevenage, Hertfordshire, United Kingdom GSK Full time
Job Title: Director, Global Regulatory Affairs

At GSK, we are seeking a highly skilled and experienced Director, Global Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and executing regional and global regulatory strategies to ensure compliance with internal GSK processes and regional regulatory requirements.

Key Responsibilities:

  • Develop and implement regional and global regulatory strategies to ensure compliance with internal GSK processes and regional regulatory requirements.
  • Lead interactions with local and regional regulatory authorities to ensure compliance with regulatory requirements.
  • Work closely with local and regional commercial teams to secure best possible labeling commensurate with available data.
  • Ensure compliance with regional requirements at all stages of product life from C2MD.
  • Advocate persuasively approaches to senior leaders in GSK and in Health Authorities.

Requirements:

  • Bachelor's degree in a relevant field.
  • Experience in Regulatory Affairs within a pharmaceutical organization.
  • Experience working with Global Health Authorities and submissions for Pharmaceutical products.

Preferred Qualifications:

  • 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.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. 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).

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.

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