Global Regulatory Affairs Leader — Diagnostics Strategy

Roche

Tucson (AZ)

Sur place

USD 347 000 - 455 000

Plein temps

Il y a 3 heures

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Avantages offerts par ce poste

Relocation benefits

Discretionary annual bonus

Résumé du poste

Roche seeks a Global Head of Regulatory Affairs to lead a high‑impact team delivering global registrations for diagnostics solutions. You will drive strategy, compliance, and stakeholder engagement across Europe, US, and APAC, ensuring rapid access to innovative products for patients.

You will build a diverse, high‑performing RA organization, partner with the Diagnostics Solutions leadership, and champion a culture of innovation and regulatory excellence, with relocation benefits and a

Qualifications

15+ years regulatory management experience preferably in international and US arena.
Experience in Dia or MedTech or both.
Proven track record of filings (510ks, PMAs, IDEs, global dossiers, registrations) and negotiations with US FDA.
Budget management experience and leadership in global/regulatory communities.
Post-graduate qualification preferred (MSc, MBA or higher).

Responsabilités

Provide strategic direction for Global Regulatory Submissions with leading teams across regions.
Serve as regulatory contact with US FDA and international agencies; coordinate submissions.
Ensure timely availability of registration data and dossiers to enable patient access.
Monitor regulatory environments and advise on impact of new regulations.
Drive standardization of regulatory processes and foster agile submission workflows.
Lead and develop the RA team, managing resources and fostering cross-functional collaboration.