Senior Global Regulatory Affairs Leader (a)

Michael Page International; Schweiz; Hybride; CHF 180 000 - 240 000; Plein temps

Résumé du poste

Michael Page International partners with a leading international pharmaceutical organisation to recruit a regulatory leader who will shape EU and global strategies and engage with health authorities.

The role offers broad cross-functional exposure, leadership of sub-teams, and a hybrid work model with onsite and home-office days. The successful candidate will drive lifecycle regulatory activities and contribute to business development on a global scale.

Qualifications

• Master's degree in Life Sciences, Pharmacy, Biotechnology or related field.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Strong EU regulatory procedural knowledge and EMA experience.
• Proven leadership in international projects and stakeholder management.
• Fluent English, written and spoken.

Responsabilités

• Define and execute EU and global regulatory strategies aligned with development objectives.
• Act as primary regulatory contact for European health authorities and coordinate interactions.
• Lead regulatory agency meetings, scientific advice procedures, and briefing documents.
• Oversee preparation and submission of regulatory dossiers across the product lifecycle.
• Drive global submission planning, milestones, and regulatory activities across markets.
• Ensure compliance of product information and labeling; represent in cross-functional teams.
• Monitor evolving regulations and assess business impact; support BD and due diligence.
• Lead regulatory sub-teams and support affiliates and external partners.

Connaissances

Regulatory leadership

Stakeholder management

Cross-functional collaboration

Communication

Strategic thinking

Formation

Master's degree in Life Sciences or related

Description du poste

• Lead EU and global regulatory strategy for innovative programmes
• High-impact role with broad cross-functional visibility

About Our Client

Our client is a leading international pharmaceutical organisation with a strong global presence and a commitment to improving patient access to healthcare solutions. Due to ongoing business needs and portfolio growth, they are looking for an experienced regulatory leader who can join the team with a quick start. Hybrid work model.

Job Description

• Define and execute EU and global regulatory strategies aligned with development objectives
• Act as the primary regulatory contact for European health authorities and coordinate regulatory interactions
• Lead regulatory agency meetings, scientific advice procedures, and preparation of briefing documentation
• Oversee preparation and submission of regulatory dossiers throughout the product lifecycle
• Drive global submission planning, execution, and regulatory milestone deliveryEnsure compliance of product information and labelling activities 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 activities
• Lead regulatory sub-teams and support affiliates and external partners on strategic regulatory matters

The Successful Applicant

• Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline
• Minimum 8 years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry
• Strong expertise in EU regulatory procedures and global regulatory frameworks
• Proven experience interacting with EMA and European health authorities
• Deep understanding of clinical development, registration pathways, and lifecycle management
• Demonstrated leadership skills within complex international projects
• Excellent stakeholder management, communication, and influencing abilities
• Fluent English, both written and spoken
• Ability to work effectively in cross-functional and global matrix environments

What's on Offer

• Strategic regulatory leadership position
• International and highly visible role
• Broad exposure to EU and global regulatory activities
• Hybrid work model (3 days onsite, 2 days HO)