Global Regulatory Expert for Pharmaceutical Diagnostics
3 weeks ago
Job Title: Global Regulatory Lead Pharmaceutical Development
Job Location: Europe
Job Type: Full-time
Salary: Estimated $120,000 - $180,000 per year
Industry: Medical Technology and Digital Solutions
Company: GE HealthCare
About the CompanyGE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits.
We offer a range of products and services that help healthcare professionals diagnose and treat patients more effectively. Our portfolio includes diagnostic imaging agents, contrast media, and molecular imaging agents used in various medical applications.
About the RoleThis is an exciting opportunity to join our team as a Global Regulatory Lead for Pharmaceutical Diagnostics. In this role, you will be responsible for developing and implementing regulatory strategies for new product introductions and single point of accountability for Global Regulatory Strategy Leadership and policy development.
You will work closely with cross-functional teams to ensure timely GRA input to global development programs and identify regulatory opportunities, potential risks, and mitigations. Your expertise will be essential in guiding internal and external stakeholders to meet business and project objectives.
We are looking for a highly motivated and experienced professional with a proven track record of leading successful Pan European, European national and US NDA/BLA licensing submissions. You should have excellent communication skills and be able to clearly convey and exchange information with internal and external stakeholders.
Essential Responsibilities- Lead assigned global program development regulatory strategy and co-ordinate with National Regulatory Affairs (NRA) regulatory submission readiness.
- Working with NRA, ensure timely GRA input to global development programs.
- For assigned programs/projects, identify regulatory opportunities, potential risks, and mitigations.
- Guide, influence and motivate, internal and external stakeholders to meet GE HealthCare business and development project team objectives.
- Fulfillment of RA compliance obligations.
- Proven track record of leading successful Pan European (CP, DCP, MRP), European national and US NDA/BLA licensing submissions.
- Proven track record of leading successful interaction with HA and relevant stakeholders.
- Proven expertise with clinical related regulations/guidance as it relates to development of product submissions.
- Knowledge of preclinical and CMC as it relates to development of product submissions
- Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery.
- Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs.
- Ability to clearly convey and exchange information with internal and external stakeholders.
We offer a competitive salary package including benefits such as health insurance, retirement plan, and paid time off. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.
We believe in fostering care, collaboration, and support within our organization. We value diversity and inclusion and strive to create an environment where every voice matters.
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