Global Regulatory Affairs Manager

1 month ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Job Title: Global Regulatory Affairs Manager

We are seeking a highly motivated and experienced Global Regulatory Affairs Manager to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for developing and implementing global and/or regional regulatory strategies for assigned assets, ensuring compliance with global and regional requirements.

Key Responsibilities:
  • Develop and implement regulatory strategies that deliver submission and approval of clinical trial applications according to agreed timescales.
  • Ensure appropriate interaction with cross-functional teams, global/regional counterparts, and local operating companies.
  • Assess precedent, regulatory intelligence, and competitive environment from a regulatory perspective for the region and its impact on the regulatory strategy for an asset.
Requirements:
  • Bachelor's degree in biological or healthcare science.
  • Experience of the drug development process in regulatory affairs.
  • Capable of leading development, submission, and approval activities in different regions globally.
  • Knowledge of clinical trial requirements in at least one region (EU or US) and ideally knowledge of other key Agency processes globally.
Preferred Qualifications:
  • PhD in biological or healthcare science.
  • Ability to foster strong matrix working, facilitating dialogue between team and matrix members to contribute their ideas.
  • Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.

GlaxoSmithKline is an Equal Opportunity Employer and adheres to Affirmative Action principles. We welcome applications from all qualified candidates and are committed to diversity and inclusion in the workplace.

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