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Global Regulatory Affairs Director

2 months ago

Rockville, Maryland, United States GlaxoSmithKline Full time

Job Summary:

We are seeking a highly skilled Global Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for developing and executing the appropriate regulatory strategy for assigned assets, across all stages of the product development and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP).

Key Responsibilities:

  • Develop and execute regulatory strategies for assigned assets, ensuring compliance with internal GSK processes/policies and regional regulatory requirements.
  • Collaborate with R&D, Medical, and Commercial teams to secure best possible labelling commensurate with available data.
  • Provide strategic regulatory input for all development stages of the project/product within a given product portfolio to key stakeholders.
  • Liaise closely with other GRA teams, such as non-clinical, CMC, Labelling, 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 all phases of the drug development process in regulatory affairs, including projects with 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 GRL for assigned assets.
  • Solid experience in procedural/registration US regulatory affairs, including as US authorized agent - liaison with US FDA.
  • Knowledge of IND and BLA regulations and US regulations pertinent to product development and licensure/post-licensure.