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Global Regulatory Affairs Director

2 months ago

Waltham, Massachusetts, United States GlaxoSmithKline Full time

Job Summary:

We are seeking a highly experienced Global Regulatory Affairs Director to lead the development and execution of regulatory strategies for our vaccines portfolio. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring compliance with regional regulatory requirements and delivering the best possible labeling for our products.

Key Responsibilities:

  • Develop and execute regulatory strategies for assigned vaccines assets, ensuring compliance with regional regulatory requirements and delivering the best possible labeling.
  • Collaborate with cross-functional teams, including R&D, Medical, and Commercial, to secure best possible labeling commensurate with available data.
  • Provide strategic regulatory input for all development stages of vaccines projects within the portfolio.
  • Liaise closely with other GRA teams, such as non-clinical, CMC, Labeling, and AdPromo, through the Regulatory Matrix Team (RMT).
  • Lead regulatory interactions and review processes in local regions, serving as the point of contact to regulatory agencies.
  • Ensure compliance with regional requirements at all stages of product life, from early development to life cycle activities.
  • Advocate scientifically sound approaches persuasively to senior leaders in GSK and at health authorities.
  • Assess potential in-license vaccines.

Requirements:

  • Bachelor's degree in biological or healthcare science.
  • Five or more years of experience in regulatory affairs, including all phases of the drug development process, with projects having little or no precedence.
  • Three or more years of experience leading regional development, submission, and approval activities in local regions.

Preferred Qualifications:

  • Master's or Ph.D. in biological or healthcare science.
  • Proven track record of successful relationships with health authorities.
  • Extensive knowledge of clinical trial and licensing requirements in the region and ideally globally.
  • Extensive knowledge of relevant areas of medicine or proven track record of developing product/therapeutic knowledge in new areas.
  • Significant external network, including other pharmaceutical companies, and recognized as an expert in regulatory affairs.
  • Able to deputize for the Global Regulatory Lead for assigned assets.
  • Solid experience in procedural/registration US regulatory affairs, including as a US authorized agent, liaison with the US FDA.
  • Knowledge of IND and BLA regulations and US regulations pertinent to product development and licensure/post-licensure.