Senior Global Regulatory Affairs Leader (a)

Michael Page; Basel; Hybride; CHF 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

Regulatory strategy

Leadership

Stakeholder management

Cross-functional collaboration

English fluency

Regulatory submissions

Formation

Master's degree in Life Sciences/Pharma

Outils

eCTD/submission management

Regulatory databases

Description du poste

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

• 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 delivery
• Ensure 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)

Quote job ref: JN-102026-7123784