Associate Director, Global Regulatory Affairs

2 days ago


Rockville, Maryland, United States GlaxoSmithKline Full time
Job Purpose:

As an Associate Director, Global Regulatory Affairs, you will be responsible for developing and executing global and/or regional regulatory strategies for assigned assets, across all stages of the product life cycle. This role requires ensuring compliance with internal GSK processes and policies, as well as relevant regulatory requirements, to deliver the best possible labeling for the asset.

Responsibilities:
  • Develop and implement regional regulatory strategies in support of global projects.
  • Lead regulatory interactions and review processes for assigned asset strategies.
  • Ensure compliance with global and regional requirements at all stages of the product life cycle.
  • Assess precedent, regulatory intelligence, and competitive environment from a regulatory perspective for assigned assets.
Qualifications:
  • Bachelor's Degree.
  • Experience in all phases of the drug development process in Regulatory Affairs.
  • Knowledge of clinical trial and licensing requirements in major countries (EU, US, JP, China).
Why 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 depends on our people, and we want GSK to be a place where people can thrive.



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