Global Regulatory Strategy Leader — Hybrid, EU & Global

Michael Page; Basel; Hybrid; CHF 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Michael Page is partnering with a leading international pharmaceutical organisation in Basel to recruit a Regulatory Leader who will shape EU and global regulatory strategies across development programs. This senior role offers broad cross-functional exposure and a quick-start environment in a hybrid work model.

The successful candidate will lead regulatory affairs, manage EMA interactions, oversee dossiers and submissions, and mentor global teams while ensuring lifecycle compliance and

Qualifications

• Master's degree in Life Sciences or related field.
• 8+ years of Regulatory Affairs in pharma/biotech.
• Strong expertise in EU regulatory procedures and global frameworks.
• Proven EMA interactions experience.
• Deep understanding of clinical development and lifecycle management.
• Demonstrated leadership in international projects.
• Excellent stakeholder management and communication.
• Fluent in English (written and spoken).

Responsibilities

• Define and execute EU and global regulatory strategies aligned with development objectives.
• Act as primary regulatory contact for European authorities and coordinate interactions.
• Lead regulatory agency meetings and preparation of briefing documents.
• Oversee preparation and submission of regulatory dossiers across product lifecycle.
• Drive global submission planning, execution, and milestone delivery.
• Ensure compliance of product information and labeling across markets.
• Represent Regulatory Affairs within cross-functional project teams and governance forums.
• Monitor evolving regulatory requirements and assess business impact.
• Provide regulatory expertise for business development, partnerships, and due diligence.
• Lead regulatory sub-teams and support affiliates and external partners.

Skills

Regulatory strategy

Leadership

Stakeholder management

Cross-functional collaboration

English fluency

Regulatory submissions

Education

Master's degree in Life Sciences/Pharma

Tools

eCTD/submission management

Regulatory databases

Job description

Michael Page is partnering with a leading international pharmaceutical organisation in Basel to recruit a Regulatory Leader who will shape EU and global regulatory strategies across development programs. This senior role offers broad cross-functional exposure and a quick-start environment in a hybrid work model.

The successful candidate will lead regulatory affairs, manage EMA interactions, oversee dossiers and submissions, and mentor global teams while ensuring lifecycle compliance and