Global Regulatory Affairs Leader
1 week ago
About the Role
The Global Regulatory Lead provides regulatory leadership to assigned projects and leads the global Regulatory Strategic Team. This role is accountable for the global regulatory strategy and oversight of implementation/execution in alignment with Regional Regulatory Leads and other regulatory strategic teams members.
Key Responsibilities
- Serve as the Regulatory point of contact on assigned projects with senior management and/or at other internal meetings providing agreed global regulatory strategic recommendations and risk assessment.
- Accountable for the timely development and implementation of the global regulatory strategy and plan(s) designed to meet the needs of the business and patients for assigned projects.
- Accountable for delivering all regulatory milestones related to assigned projects including assessment of the approvability of program submissions together with global regulatory risk mitigation measures.
Requirements
- Bachelor's degree
- Several years' experience in pharmaceutical regulatory affairs
- Knowledge of global regulatory procedures and legislation for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension, and license maintenance
What We Offer
UCB is a global biopharmaceutical company dedicated to the discovery and development of innovative medicines and solutions to transform patients' lives.
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