Global Regulatory Strategy Lead

CSL Plasma Inc.

Bern

Hybrid

CHF 110.000 - 140.000

Vollzeit

Vor 5 Tagen

Sei unter den ersten Bewerbenden

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Zusammenfassung

CSL Behring is seeking a Regulatory Affairs professional to lead planning and execution of regulatory activities in Switzerland. You will manage permits, licenses, and registrations while monitoring regulatory trends and advising leadership.

The role focuses on building strong government relationships and preparing documentation for counsel, with opportunities to work on biologics programs in a global biotherapeutics company.

Qualifikationen

Bachelor’s degree in life science or business; advanced degrees are an advantage.
3+ years of regulatory experience in the pharmaceutical industry; biologics experience preferred.

Aufgaben

Plan, direct, and monitor regulatory affairs activities to obtain permits and approvals.
Support development of consistent roles and work processes.
Oversee plans, cost estimates, and schedules; acquire permits and approvals.
Monitor regulatory developments and advise management on impacts.
Establish and maintain relationships with government agencies and authorities.
Represent the organization before regulatory, legislative, or industry bodies.
Prepare materials for legal counsel or external consultants.
Create and compile registration application documentation.
Regulatory system data entry and maintenance.

Kenntnisse

Regulatory affairs

Life science degree

Biologics experience

Pharma industry

Advanced degree advantageous

Ausbildung

Bachelor in Life Science

Business degree

Advanced degree (PhD/MD/MBA) advantageous

Jobbeschreibung