Director of Regulatory Excellence
Vor 2 Tagen
We are looking for an experienced Regulatory Affairs Director to join our team in Zurich, Switzerland. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regional regulatory strategies to support the approval and commercialization of our products.
Key Responsibilities- Develop Regulatory Strategies: Collaborate with cross-functional teams to develop and implement regional regulatory strategies that align with business objectives.
- Manage Regulatory Submissions: Oversee and manage regional regulatory submissions, ensuring timely approvals throughout product development and lifecycle.
- Provide Regulatory Expertise: Offer strategic advice on emerging trends, regulations, and changes, and provide regulatory expertise on drug development, registration, and post-marketing compliance.
- Represent Takeda: Represent the company in Health Authority meetings and negotiations, effectively communicating and managing meeting outcomes and next steps.
- Education: BSc or BA degree in a scientific field, preferably with experience in drug regulatory affairs.
- Experience: A minimum of 8 years of experience in drug regulatory affairs, preferably within the EU/GEM region.
- Regulatory Knowledge: Solid understanding of regulations and guidance applicable in the region, across all phases of development.
- Communication Skills: Effective communication skills, including the ability to present complex scientific information in a clear and concise manner.
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Regulatory Affairs Director
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Stäfa, Zürich, Schweiz Takeda VollzeitJob OverviewThis role is responsible for developing and leading regional regulatory strategies to maximize regulatory success and strengthen product development plans. The ideal candidate will have a strong background in drug regulatory affairs, preferably within the EU/GEM region.Key ResponsibilitiesDefine and Develop Regulatory Strategies: Collaborate with...
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vor 18 Stunden
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