Global Regulatory Affairs Director

6 days ago


Rockville, Maryland, United States GlaxoSmithKline Full time
Job Summary

We are seeking a highly skilled and experienced Global Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, 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.

Key Responsibilities
  • Develop and implement global and/or regional regulatory strategies for assigned assets, ensuring compliance with internal GSK processes and policies, as well as relevant regulatory requirements.
  • Lead interactions with local and regional regulatory authorities, ensuring effective communication and collaboration.
  • Proactively develop regulatory strategies, considering the needs of other regions globally, and implement regional strategies in support of global projects.
  • Ensure compliance with global and regional requirements at all stages of the product life cycle, and assess precedent, regulatory intelligence, and competitive environment from a regulatory perspective.
  • Collaborate with global and regional counterparts, as well as commercial teams, to ensure a robust regulatory strategy is in place to support product licensure in key markets and secure best possible labeling.
Requirements
  • Bachelor's Degree in a relevant field, with experience in all phases of the drug development process in Regulatory Affairs.
  • Knowledge of clinical trial and licensing requirements in major countries, including the EU, US, JP, and China, and ideally knowledge of other key agency processes globally.
  • Relevant therapy area knowledge and ability to further develop specialist knowledge for the product or area of medicine.
Preferred Qualifications
  • Capable of leading regulatory development, submission, and approval activities in assigned regions.
  • Higher degree in biological or healthcare science.


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