Director of Global Regulatory Affairs

6 days ago


Cambridge, Massachusetts, United States GlaxoSmithKline Full time
Job Title: Director, Global Regulatory Affairs

GlaxoSmithKline is seeking a highly skilled and experienced Director, Global Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and leadership on regulatory matters related to our RNA vaccines.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with FDA regulations and guidelines.
  • Lead cross-functional teams to prepare and submit regulatory documents, including INDs, BLAs, and Q&As.
  • Collaborate with internal stakeholders to ensure regulatory requirements are met and aligned with business objectives.
  • Provide regulatory expertise and guidance to project teams on clinical, CMC, and labeling aspects.
  • Stay up-to-date with changes in regulatory guidelines and rules, and communicate their impact on regulatory strategy.
Requirements:
  • Bachelor's degree and 10+ years of experience in regulatory affairs, or advanced degree and 5+ years of experience.
  • Experience in scientific and regulatory affairs in all stages of product development.
  • Knowledge of IND and NDA/BLA regulations and US regulations pertinent to product development and licensure.
  • Excellent communication and leadership skills.
Preferred Qualifications:
  • Experience at a large pharmaceutical/vaccines company.
  • Strong strategic leadership skills.
  • Experience working successfully in a matrix environment.

GlaxoSmithKline is an equal opportunity employer and welcomes applications from diverse candidates. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.



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