Eucan Regulatory Affairs Director

Vor 3 Tagen

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

Leads all regulatory activities related to the creation, submission and maintenance of CTAs in Europe, through the EU Clinical Trial Information System (CTIS) or legacy processes in conformity with legal requirements and with Takeda’s global and regional internal procedures.
- Accountable for oversight and tracking of CTA activities. Works in collaboration with CRO to ensure CTIS compliance including but not limited to highlighting non-submission specific activities required for CTIS maintenance to study teams.
- Coordinate overarching support for CTAs across TAs via the monitoring of cross study activities to ensure identification and communication of trends or emerging changes that have potential cross study impact.
- Provides leadership and development for multiple direct reports for the design and execution of regulatory clinical trial strategies in collaboration with their regional stakeholders.
- Provides direction to senior leadership and teams on emerging trends, regulations and changes, enabling proactive approach and planning to future business requirements.
- Support organizational awareness, as appropriate for changes in regulations
- Coordinates submission preparations process and creation of administrative documents to support CTA filings or lifecycle activities (in collaboration with CROs where applicable)
- Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**
- BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred.
- Demonstrated ability to work and communicate effectively with others, collaborate and build relationships across all levels of an organization.
- Strong knowledge of industry standards and/or regulatory requirements, especially related to clinical trials/EU CTR
- Excellent written, communication, project management and presentation skills (articulate and persuasive). Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships

**Locations**:
Zurich, Switzerland

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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