Global Regulatory Affairs Director: Audits & Compliance

Takeda; Opfikon; On-site; CHF 177,000 - 244,000; Full time

Job summary

Takeda in Zurich, Switzerland is seeking a Director of Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) to lead regulatory readiness and compliance across global operations. The role focuses on high-risk, high-value activities, driving a culture of compliance and scalable improvements.

You will guide cross-functional teams, manage inspections, and develop regional leaders, shaping processes and systems with a strong governance voice.

Qualifications

• 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.
• Experience with global health authorities, PV, license maintenance, product approval and lifecycle processes across major markets.

Responsibilities

• 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.

Skills

Audit & Inspections

Regulatory Compliance

Leadership

Cross-functional

Project Management

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva RIM

Veeva Quality

TrackWise

MS Office

Job description

Takeda in Zurich, Switzerland is seeking a Director of Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) to lead regulatory readiness and compliance across global operations. The role focuses on high-risk, high-value activities, driving a culture of compliance and scalable improvements.

You will guide cross-functional teams, manage inspections, and develop regional leaders, shaping processes and systems with a strong governance voice.