Regulatory Affairs Global Program Manager
For one of our clients, a well-established organization focusing on developing innovative medicines for improving people’s health and quality of life through a public-private partnership model, we are currently looking for an enthusiastic Regulatory Affairs Global Program Manager for an initial 6-months contract based in Basel.
As an ideal candidate you should have 3+ years of experience with regulatory submissions and approval processes for 1 or more regions, and negotiating with Health Authorities within the Pharmaceutical industry.
As a Regulatory Affairs Global Program Manager you will provide strategic and operational regulatory direction and may support the Drug Regulatory Affairs (DRA) Global Program Team (GPT) representative and the Global Therapeutic Area Lead (GTAL) for programs through development, registration and approval/post approval.
- Responsible for implementing regulatory strategy and managing operational activities for assigned regions;
- Coordinating and implementing regulatory readiness with other line functions, including key opinion leaders;
- Determining requirements and setting objectives for Health Authority (HA) interactions;
- Facilitating preparation and finalization of briefing books;
- Developing and implementing plans for timely response to HA‘s requests and coordinating responses;
- Responsible for integrating global strategy into regional submissions worldwide;
- Contributing to identification of issues, gaps and tradeoffs affecting optimal and timely submission and approval;
- Coordinating, planning and preparing for submission of dossiers in assigned regions worldwide;
- Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs);
- Contributing to the development of the Development Core Data Sheet (DCDS);
- Contributing to identifying potential label issues/gaps and developing regulatory label negotiation strategy with contingency planning;
- Responsible for finalization and on time submission of annual reports and renewals across assigned regions.
Qualifications and Experience:
- Science based BSc or MSc with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred;
- 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 negotiating with Health Authorities;
- 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV;
- Understanding of post-marketing/brand optimization strategies and commercial awareness preferred;
- Strong interpersonal, communication, negotiation and problem solving skills;
- Fluent in English. Other languages an asset;
- Relevant working/residency permit or Swiss/EU-Citizenship required.