Senior Global Regulatory Affairs Leader (a)

Basel-Region Festanstellung View Job Description
Our client is seeking a senior Regulatory Affairs professional to drive EU and global regulatory strategies across complex development and lifecycle programmes. This role combines strategic leadership, health authority interaction, submission oversight, and cross-functional project leadership in an international environment.

hinzugefügt 12/10/2026

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

Firmenprofil

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.

Stellenbeschreibung

  • 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



Anforderungsprofil

  • 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



Sonstige Informationen

  • 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)



Referenznummer angeben
JN-102026-7123784

Zusammenfassung

Berufsfeld
Healthcare & Life Sciences
Näheres Berufsfeld
Regulatory Affairs
Branche
Healthcare / Pharmaceutical
Ort
Basel-Region
Vertragsart
Permanent
Referenznummer
JN-102026-7123784

Die Michael Page verpflichtet sich zu Chancengleichheit, als Arbeitgeber genauso wie als Dienstleistungsunternehmen. Wir treffen Rekrutierungsentscheidungen ausschließlich basierend auf Erfahrungen und Fähigkeiten der Bewerberinnen und Bewerber. Diese Maxime gilt nicht nur für unsere Mitarbeiterinnen und Mitarbeiter, sondern auch für unsere Arbeit in der Recruiting-Branche.