Director of Global Regulatory Affairs

2 weeks ago


Rockville, Maryland, United States GSK Full time
Director, Global Regulatory Affairs - RNA Vaccines

Lead Regulatory Strategy for RNA Vaccines

GSK is seeking a highly skilled Director, Global Regulatory Affairs to lead the regulatory strategy for our RNA vaccines portfolio. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory plans to ensure compliance with global regulatory requirements.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with global regulatory requirements
  • Lead cross-functional teams to develop and submit regulatory documents to FDA and other regulatory agencies
  • Provide regulatory expertise to support the development and commercialization of RNA vaccines
  • Collaborate with internal stakeholders to ensure alignment with business objectives
  • 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
  • Experience in clinical regulatory affairs and CMC regulatory affairs for pre-licensed and licensed biologic products or vaccines
  • Knowledge of IND and NDA/BLA regulations and US regulations pertinent to product development and licensure
  • Knowledge of scientific basis for clinical development, endpoints, and product CMC
  • Experience as liaison with US FDA

Preferred Qualifications:

  • Experience at a large pharmaceutical/vaccines company
  • Excellent communication skills
  • Experience working successfully in a matrix environment
  • Strong leadership skills

About GSK:

GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

Why GSK?

GSK is a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.



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