Global Regulatory Affairs Director, Compliance & Audit Lead

Takeda Pharmaceutical Co.; Glattbrugg; On-site; CHF 177,000 - 244,000; Full time

Job summary

Takeda Pharmaceutical Co. in Zurich, Switzerland invites a seasoned Director to lead Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) for Product Lifecycle Management.

You will drive audit readiness, regulatory compliance, and cross-functional collaboration across regions to strengthen processes and insights. The role requires 12+ years in pharma with 3+ years in regulatory affairs and in people leadership, plus hands-on experience with health authorities and systems like

Qualifications

• Bachelor’s degree in a science or business-related field; MSc or PhD preferred.
• 12+ years in pharmaceutical industry experience, including 3+ years in Regulatory Affairs/Quality/Compliance.
• 3+ years of people leadership experience.
• Strong expertise in audits, inspections, regulatory compliance and inspection readiness.
• Knowledge of global Health Authorities, PV, license maintenance, and lifecycle processes across major markets.

Responsibilities

• Lead GRA audit and inspection readiness, execution, follow-up and continuous improvement.
• Act as the key GRA contact for audits, inspections, and regulatory compliance matters.
• Lead and develop regionally aligned team members ensuring consistent execution across regions.
• Provide regulatory compliance guidance to cross-functional and regional partners.
• Lead cross-functional workstreams to implement compliance requirements and processes.
• Assess new global regulatory GxP and compliance requirements and evaluate their 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.

Skills

Regulatory leadership

Audits & inspections

Cross-functional collaboration

Regulatory risk assessment

Education

PhD preferred

MSc preferred

Bachelor's degree in science or business

Tools

Veeva RIM

Veeva Quality

TrackWise

Microsoft tools

Job description

Takeda Pharmaceutical Co. in Zurich, Switzerland invites a seasoned Director to lead Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) for Product Lifecycle Management.

You will drive audit readiness, regulatory compliance, and cross-functional collaboration across regions to strengthen processes and insights. The role requires 12+ years in pharma with 3+ years in regulatory affairs and in people leadership, plus hands-on experience with health authorities and systems like