Director Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) – Product Lifecycle Management

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Job Description

About the Role

As Director, Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) – Product Lifecycle Management, you will provide strategic leadership to strengthen regulatory compliance and inspection readiness across Takeda’s global and regional operations, driving a compliance culture and focusing the teams efforts on the highest-risk and highest-value activities.

You will lead audit and inspection support across Global Regulatory Affairs, from readiness and execution through post-inspection activities and continuous improvement. You will also work across functions and regions to strengthen processes and systems, identify compliance risks, and ensure consistent implementation of regulatory requirements. The best candidate for this role will anticipate challenges, develop scalable solutions, and build organizational capability driving everyday compliance.

How You Will Contribute

• Lead GRA audit and inspection readiness, execution, follow-up activities and continuous improvement.
• Act as the key GRA contact for Global and R&D Quality on audits, inspections and regulatory compliance matters.
• Lead and develop regionally aligned team members, ensuring consistent execution and collaboration across regions.
• Provide regulatory compliance guidance and leadership to cross-functional and regional partners.
• Lead cross-functional workstreams to implement compliance requirements, processes and systems.
• Assess new and revised global regulatory GxP and compliance requirements and evaluate their operational impact.
• Develop and monitor GRA metrics related to regulatory commitments, audits, inspections and Health Authority requests.
• Identify and communicate compliance risks, issues and trends to GRA leadership.
• Oversee issue resolution and CAPAs, driving continuous improvement, automation and process excellence opportunities.

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What You Bring to Takeda

• Bachelor’s degree in a science or business-related field; MSc or PhD preferred.
• 12+ years of pharmaceutical industry experience, including at least 3 years within Regulatory Affairs, R&D and/or Quality/Compliance.
• Minimum 3+ years of people leadership experience.
• Strong expertise in audits, inspections, regulatory compliance and inspection readiness.
• Proven ability to identify, assess and mitigate compliance risks in complex environments.
• Strong knowledge of global Health Authorities, PV, license maintenance, product approval and lifecycle processes across major markets including the USA, EU, UK, Japan, China and Brazil.
• Experience working effectively across functions, regions and cultures in a global matrix environment.
• Strong leadership, stakeholder management and cross-functional collaboration skills.
• Excellent project management, analytical, problem-solving and communication capabilities.
• Experience with Veeva RIM, Veeva Quality, TrackWise and Microsoft platform solutions.

Locations

Zurich, Switzerland

Base Salary Range:

CHF177,400.00 - CHF243,980.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time