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Regulatory Affairs Director Lead

2 months ago

West Midlands Combined Authority, United Kingdom CTI Clinical Trial and Consulting Services Full time
Job Description:

As a Senior Regulatory Affairs Director, you will spearhead the development and implementation of a global regulatory strategy for increasingly complex products. Your primary goal is to ensure that the strategy enables rapid approval with favorable labeling, aligning with product properties and business needs.

Key Responsibilities:
  • Provide strategic leadership in global regulatory science and overall drug/biologic development processes
  • Lead the planning and construction of global dossiers and core prescribing information
  • Conduct regulatory risk assessment and mitigation
  • Lead the Global Regulatory Sub-team (GRST) and oversee key contributors from various regional perspectives
  • Accountable for delivering all regulatory milestones, including probability of success assessments and risk mitigation measures

You will also be responsible for maintaining and ensuring compliance for marketed brands, leading the objective assessment of emerging data, and providing critical updates to senior management on project risks and mitigation activities.