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Position Summary:•Provide regulatory strategic oversight for 2+ therapeutic areas or one highly complex therapeutic area with multiple products to ensure regulatory compliance of promotional materials generated for assigned compounds.•Understands and interprets complex scientific issues as it relates to regulatory requirements and promotional strategy. Responsible for all regulatory aspects of multi-disciplinary ...
Position Summary:The Senior Global Submission Specialist is accountable for the timely delivery of compliant submissions. The position promotes an e-working environment and drives efficient, standardized best practices for regulatory submission document management. Assigned to a specific project, partnering with the Global Regulatory Lead and as manager of a cross-functional submission ...
POSITION SUMMARY: • The Senior GMP Quality Auditor is responsible for planning, executing, reporting, tracking, and closing GMP audits of complex and high-risk third-party vendors and suppliers throughout Takeda’s pharmaceutical development supply chain.• This position leads monitoring & oversight efforts to ensure compliance of key Takeda vendors, tracking quality performance ...