Regulatory Affairs Director

2 weeks ago

Rockville, Maryland, United States GlaxoSmithKline Full time
Job Title: Regulatory Affairs Director

At GlaxoSmithKline, we are committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are seeking a highly skilled Regulatory Affairs Director to join our team and play a key role in ensuring the development and execution of our regulatory strategy.

Key Responsibilities:
  • Develop and execute regulatory strategies for assigned assets, across all stages of product development, consistent with our Vaccines Development Strategy/Integrated Asset Plan (IAP).
  • Ensure compliance with internal GSK processes/policies and regional regulatory requirements to deliver the best possible labelling commensurate with available data.
  • Work closely with R&D, Medical, and Commercial teams to secure best possible labelling commensurate with available data.
  • 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, e.g., be the point of contact to CBER for assigned assets.
  • Ensure appropriate interaction with regional commercial teams in local regions.
  • Ensure compliance with regional requirements at all stages of product life, from early development to life cycle activities.
  • Proven capability to advocate scientifically sound approaches persuasively to senior leaders in GSK and at Health Authorities.
  • Capable of providing assessment of potential in-license vaccines.
Basic Qualifications:
  • 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 in leading regional development, submission, and approval activities in local regions.
Preferred Qualifications:
  • MS or PhD in biological or healthcare science.
  • Capable of organizing and executing successful milestone meetings and with a track record of successful relationships with one or more Health Authorities.
  • Extensive knowledge of clinical trial and licensing requirements in regions and ideally sound knowledge globally.
  • Extensive knowledge of relevant areas of medicine or proven track record of being able to develop product/therapeutic knowledge in new areas.
  • Ideally also a significant external network at least into other pharmaceutical companies and recognized internally and externally as an expert broadly or in specific areas of regulatory affairs.
  • Able to deputize for GRL for assigned assets.
  • A solid experience in procedural/registration US regulatory affairs (including as US authorized agent - liaison with US FDA).
  • Knowledge in IND and BLA regulations and US regulations pertinent to product development and licensure/post-licensure.

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