Regulatory Affairs Director

4 days ago


Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
Job Purpose:

As a key member of our team, you will be responsible for developing and executing regional regulatory strategies that align with our Medicines Development Strategy. This involves ensuring compliance with internal GSK processes and policies, as well as regional regulatory requirements to deliver the best possible labeling commensurate with available data.

Key Responsibilities:
  • Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans.
  • Lead interactions with local / regional regulatory authorities.
  • Ensure the regulatory strategy will deliver the needs of the local region(s), taking into account the needs of other regions globally.
  • Implement the regional strategy(s) in support of the project globally.
  • Ensure compliance with regional requirements at all stages of product life from C2MD.

Requirements:
  • Bachelor's degree.
  • 5+ years of experience in Regulatory Affairs in a regulated environment.
  • Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
  • Proven experience of leading regional development, submission and approval activities in local region(s).
  • Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority.

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. Our success absolutely depends on our people. 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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