Regulatory Affairs Expert EU and Global Markets
vor 2 Wochen
Takeda is seeking an experienced Regulatory Affairs Expert EU and Global Markets to join our team. As a key member of our regulatory affairs department, you will play a critical role in shaping our global regulatory strategy for drug-device combination products.
Your primary responsibility will be to develop and implement innovative regulatory strategies that drive the development, registration, commercialization, and life cycle management of assigned asset programs in EU and Global Markets.
You will utilize your technical knowledge, regulatory expertise, and global regulatory lessons learned to shape global regulatory best practices, drive internal consistency, and influence effective change management.
Key Responsibilities- Develops and implements regulatory strategies for drug-device combination products in EU and Global Markets.
- Leverages technical knowledge and regulatory expertise to shape global regulatory best practices.
- Built strong relationships with key internal and external stakeholders.
- 8+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for drug-device combination products in EU & Global Markets.
- Experience working on cross-functional submission teams.
- Demonstrates emerging leadership, problem-solving ability, flexibility, and teamwork.
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