- Financial Services: P&C Insurance, Health Insurance, Reinsurance, Banking
- Public sector
To strengthen our Life Sciences team in the German part of Switzerland we are looking for a Global Program Regulatory Manager (GPRM) Consultant.
Global Program Regulatory Manager (GPRM) - Life Sciences [f/m]
Role / Main Task
The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the GPRD for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the GPRD. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the Drug Regulatory Affairs Development (DRA) subteam and may indirectly report to the GPRD for the project and may have responsibility for leading regional DRA subteams.
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
Fluency in English as a business language. Additional language is an asset.
Experience with regulatory submission and approval processes in 1 or more major regions.
Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.
Experience in Health Authority negotiations.
2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:
Innovation in regulatory strategy.
Understanding of post-marketing/brand optimization strategies and commercial awareness preferred.
Involvement in an dossier submissions and approvals
Drug regulatory submission and commercialization in region.
Analysis and interpretation efficacy and safety data.
Regulatory operational expertise.
Strong interpersonal, communication, negotiation and problem solving skills.
Basic organizational awareness (e.g., interrelationship of departments, business priorities).
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