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Director, Global Regulatory Lead
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- The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders.
- The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met while leveraging expedited pathways where appropriate.
- The individual has regulatory affairs departmental and cross functional influence and acts as an advisor/liaison to the global project teams to plan, evaluate and recommend regulatory strategy.
- Supports the preparation and submission of global regulatory documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met including the review global submission documents in support of clinical trials and marketing applications, and their amendments to support investigational and marketing registration packages throughout the world.
- Supports regional team to negotiate with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
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