Compliance (Regulatory Affairs) - Vice President
2 weeks ago
Vice President Regulatory Affairs
Job Type: Permanent
Vice President of Regulatory Affairs
Offering a lucrative Salary and Benefit package
Oxford based – flexible working available
Currently looking for a Vice President of Regulatory Affairs this is opportunity is perfect for a strong strategic regulatory leader who has extensive experience working as a strategic decision maker.
Strategic leadership of the global regulatory affairs team.
Act as an independent subject matter expert to various project teams and departments, with particular close collaboration with the clinical operations and research departments.
Keep abreast of global regulatory requirements and assessing risks, developing contingency plans.
Overseeing coordination of regulatory submissions, strategizing for dossier updates, and submission of new INDs/CTAs/NDAs/MAAs.
A minimum of 10-15 years global Regulatory experience supporting UK & China affiliates
Proven expertise in regulatory submission and approval processes, and in resolving complex CMC regulatory issues
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