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Global Regulatory Manager

3 months ago

London, UK, United Kingdom Meet Full time

My client is a leading company focused on developing innovative solutions in the healthcare sector. Their commitment to regulatory excellence ensures they deliver safe and effective medicinal products worldwide.


Position Summary:

The Global Regulatory Strategy Manager is responsible for developing and executing global and local regulatory strategies to obtain and maintain market approval for medicinal products in the assigned therapeutic area. The role involves being a key member of the Global Regulatory Strategy Team (GRST) and providing regulatory guidance to innovation and marketing teams.


Key Responsibilities:

  • Provide direction and expertise on global and local regulatory mechanisms as part of the Global Regulatory Strategy Team (GRST).
  • Collaborate with global marketing and innovation teams to support new product development and market rollouts.
  • Partner with local regulatory teams to ensure effective implementation of global strategies.
  • Ensure global regulatory strategies align with business objectives and comply with current regulations.
  • Monitor external regulatory environments to inform decision-making.
  • Develop relationships with national regulatory agencies.
  • Maintain awareness of new legislation and regulatory policies relevant to
  • Analyze legislation, regulations, and guidance to provide analysis to the organization.


Candidate Requirements:

  • Knowledge of regulatory principles, policies, procedures, and SOPs.
  • Understanding of regulatory activities and their impact on projects.
  • Knowledge of relevant European guidelines and regulations.
  • Awareness of registration procedures and challenges for MAs.
  • Scientific background with a master’s degree in pharmaceutics, healthcare, life sciences, or related fields preferred.
  • 5 to 10 years of experience in a similar role, preferably internationally.
  • Fluent English communication skills (written and oral).
  • Determined, persuasive, and communicative personality.


Competencies:

  • Strong team player with the ability to work effectively in diverse teams.
  • Ability to work independently and collaboratively.
  • Highly ethical, honest, reliable, and accountable.
  • Positive "can-do" attitude.
  • Accurate, decisive, and solution-oriented.
  • Good communication and presentation skills.
  • Ability to manage concurrent projects with varying instructions.