Senior Regulatory Specialist, Device and Drug-Device Combinations EU and Global Markets
Vor 7 Tagen
About the Role
Takeda is seeking a highly skilled and experienced Regulatory Affairs professional to join our team as a Senior Regulatory Specialist, Device and Drug-Device Combinations EU and Global Markets. In this role, you will be responsible for developing and implementing innovative regulatory strategies for drug-device combination products in EU and Global Markets.
Key Responsibilities
- Develop and implement regulatory strategies for drug-device combination products in EU and Global Markets
- Collaborate with cross-functional teams to ensure regulatory compliance and effective change management
- Build and maintain strong relationships with key stakeholders, including regulatory authorities and internal teams
- Provide regulatory guidance and support to product teams, ensuring alignment with EU and Global Markets regulatory strategies
- Identify and mitigate regulatory risks, ensuring timely communication with line management
Requirements
- 8+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for drug-device combination products in EU and Global Markets
- Experience working on cross-functional submission teams
- Solid understanding and proven ability to provide strategy on regulatory requirements relevant to global drug-device combination product development, registration, and post-market support
- Excellent written and oral communication skills, with cross-organization stakeholder engagement
What We Offer
- Opportunity to work with a world-class R&D organization
- Collaborative and dynamic work environment
- Competitive compensation and benefits package
Location
Zurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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