Senior Regulatory Director - Drug-Device Combinations

F. Hoffmann-La Roche AG

Basel

Vor Ort

CHF 180.000 - 240.000

Vollzeit

Vor 2 Tagen

Sei unter den ersten Bewerbenden

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Zusammenfassung

Roche Pharma in Basel seeks a Principal Regulatory Program Director to turn regulatory complexity into strategic advantage across portfolio delivery and global policy shaping. You will steward device and CMC regulatory frameworks with PK/BE bridging knowledge and drive cross-disciplinary execution.

You will shape global regulatory strategy for drug-device combinations, mentor teams, and collaborate with internal stakeholders to accelerate development while engaging with health authorities to set

Qualifikationen

Bachelor's degree in engineering or related scientific discipline; advanced degree preferred.
Minimum extensive experience in regulatory affairs and drug/device contexts.
Global regulatory strategy expertise across device and pharmaceutical domains.
Proven track record with health authority interactions and major approvals.

Aufgaben

Architect and drive global regulatory strategy for complex drug-device technologies.
Provide strategic risk management and high-level regulatory guidance.
Partner with internal stakeholders across Pharma Technical and Development.
Lead senior regulatory consultation to align with health authority expectations.
Represent Roche Pharma in external policy venues and industry groups.

Kenntnisse

Regulatory strategy

Leadership

Stakeholder management

Ausbildung

Bachelor's in engineering

Advanced degree preferred

Jobbeschreibung

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