Head of Regulatory Affairs

3 weeks ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Position Overview:

As a key member of our team, you will be responsible for shaping and executing regional regulatory strategies for assigned assets in alignment with our overarching Medicines Development Strategy. Your role will ensure compliance with both internal policies and regional regulatory standards, aiming to achieve optimal labeling based on available data.

Key Responsibilities:
  • Collaborate with the Global Regulatory Lead and Global Regulatory Therapeutic Area Head to develop and implement effective regulatory strategies.
  • Act as the primary contact for assigned assets, overseeing both regional and global regulatory approaches.
  • Engage in long-term planning and execution, working across various departments within the organization to ensure alignment with regulatory requirements.
  • Partner with local and regional commercial teams to secure favorable labeling outcomes.
  • Lead regulatory discussions and manage review processes with local authorities.
  • Ensure that regulatory strategies address the specific needs of local regions while considering global implications.
  • Implement regional strategies that support global project objectives.
  • Maintain compliance with regulatory requirements throughout the product lifecycle.
  • Advocate effectively for regulatory approaches to senior leadership and health authorities.
  • Evaluate potential in-licensing opportunities for new molecules.
Qualifications:

Basic Qualifications:
We seek professionals with the following essential skills:
  • Bachelor's degree in a relevant field.
  • Experience in Regulatory Affairs within the pharmaceutical sector.
  • Familiarity with Global Health Authorities and submission processes for pharmaceutical products.
Preferred Qualifications:
If you possess the following attributes, it would be advantageous:
  • Advanced degree (PhD or Master's) in life sciences or pharmacy.
  • Strong technical expertise to assess regulatory compliance of products.
  • Proven ability to engage with regulatory officials and support advocacy initiatives.
Why Join Us?

At GlaxoSmithKline, we are committed to uniting science, technology, and talent to advance healthcare. Our mission is to positively impact the health of billions and deliver sustainable shareholder returns while fostering an environment where our employees can thrive. We focus on innovative solutions in vaccines, specialty, and general medicines, with a strong emphasis on the science of the immune system and cutting-edge technologies across four key therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.

We value our people and strive to create a workplace where everyone feels inspired, valued, and included. If you share our vision, we invite you to explore opportunities with us.

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