Head of Regulatory Strategy

3 weeks ago

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

As a pivotal member of our team, you will be responsible for shaping and executing regional regulatory strategies for assigned assets, ensuring alignment with our overarching Medicines Development Strategy. Your role will be critical in maintaining compliance with both internal policies and regional regulatory frameworks, ultimately striving for optimal product labeling based on available data.

Key Responsibilities:
  • Serve as the primary contact for assigned assets, accountable for the development and execution of regional and global regulatory strategies.
  • Engage in long-term planning, collaborating extensively across GSK to ensure successful delivery of regulatory objectives.
  • Work closely with local and regional commercial teams to achieve the best possible labeling outcomes.
  • Lead and manage interactions with local and regional regulatory authorities.
  • Ensure that regulatory strategies address the specific needs of local regions while considering global requirements.
  • Implement regional strategies that support global project goals.
  • Oversee regulatory interactions and review processes within the local region.
  • Maintain compliance with regional regulations throughout the product lifecycle.
  • Advocate effectively for regulatory approaches to senior leadership and health authorities.
  • Evaluate potential in-licensing opportunities for molecules.
Qualifications:

Basic Qualifications:
We seek professionals with the following essential skills:
  • Bachelor's degree in a relevant field.
  • Proven 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.
  • Ability to engage with regulatory officials and support advocacy initiatives.
Why Join Us?

At GSK, we are committed to uniting science, technology, and talent to advance healthcare. Our mission is to prevent and treat diseases through innovative vaccines and medicines, focusing on key therapeutic areas such as infectious diseases, HIV, respiratory conditions, and oncology.

We believe that our success is driven by our people. We strive to create an environment where everyone feels inspired, valued, and included. We encourage personal growth and prioritize well-being, making GSK a place where you can thrive.

As an Equal Opportunity Employer, we welcome diverse talent and are committed to inclusivity in our hiring practices. We also promote an agile working culture, allowing flexibility in how and where we work. Join us on our journey to make a meaningful impact on global health.

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