Global Regulatory Affairs Director - Audits & Compliance

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

Job summary

Takeda Pharmaceutical Co. invites a strategic leader to steer Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) for Product Lifecycle Management.

This role shapes audit readiness, regulatory risk oversight, and cross-functional collaboration across regional teams to strengthen compliance culture and lifecycle processes. You will drive readiness for inspections, guide CAPA programs, and implement scalable solutions with a focus on high-risk, high-value activities in a global

Qualifications

• Bachelor’s degree in science or business; MSc/PhD preferred.
• 12+ years in pharmaceutical industry with at least 3 years in 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 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 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

Regulatory Compliance

Audits & Inspections

Leadership

Cross-functional teamwork

Project Management

Communication

Problem Solving

Education

Bachelor’s degree in science or business

MSc/PhD preferred

Tools

Veeva RIM

Veeva Quality

TrackWise

Microsoft Office

Job description

Takeda Pharmaceutical Co. invites a strategic leader to steer Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) for Product Lifecycle Management.

This role shapes audit readiness, regulatory risk oversight, and cross-functional collaboration across regional teams to strengthen compliance culture and lifecycle processes. You will drive readiness for inspections, guide CAPA programs, and implement scalable solutions with a focus on high-risk, high-value activities in a global