Eucan Associate Regulatory Affairs Director
Vor 2 Tagen
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **EUCAN Associate Regulatory Director - Clinical Trials**, based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.**
**OBJECTIVE**:
Provides supervision to junior team members to support / and performs:
- Executes or oversees all 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.
- Ensures oversight and tracking of CTA activities and eTMF updates performed by the CRO Regulatory Lead. 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.
- Provides 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.
- Ensures communication of new requirements and trends at an organisational level and provides strategic and tactical advice and guidance to teams, as required, to address emerging CTA requirements.
**ACCOUNTABILITIES**:
- Accountable for oversight and coaching/support training of junior colleagues and supporting cross study initiatives.
- 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
- Identifies regional/national requirements to support submissions
- Provides proactive input during tactical planning on latest regulatory trends and potential solutions for challenges identified.
- Ensures all necessary documentation is made available for submission and internally approved as appropriate
- Coordinates submission preparations process and creation of administrative documents to support CTA filings or lifecycle activities (in collaboration with CROs where applicable)
- Ensures accurate and timely submissions and communication of key events throughout clinical trial lifecycle (e.g., oversight of initial CTA compilation in CTIS to ensure CTA aligns with Takeda expectations, communication cascade of approval notification of IB etc)
- Supports development of appropriate grouping and sequencing plans for changes impacting multiple studies. (Either organisationally driven or in complex clinical programmes)
- Provides regional regulatory oversight of CRO activities as applicable to ensure that activities are tracked, and appropriate systems are maintained in a compliant manner (e.g., CTIS, eTMF). As applicable provides support for overall company level CRO support related discussions.
- Supports regulatory responses processes as requested by EUCAN Regulatory Lead
- Supports ad-hoc filings as required during CTA lifecycle
- Upon request, provides ad-hoc guidance to teams related to latest submission requirements and experiences for clinical trials in EU.
- Works as part of team to provide proactive solutions to problems arising during the CTA processes in conjunction with senior team member and/or EUCAN Regulatory Lead, as applicable.
For non-submission strategy related items:
- defines, refines and supports the maintenance of appropriate internal knowledge base on emerging information and trends with regulators for clinical trials. e.g., list of all clinical trials supported via CTIS, general awareness tracking systems (to be developed - e.g., internal timings tracker etc)
- Support organisational awareness, as appropriate for changes in regulations
- Ensures appropriate oversight of CTIS to ensure that non-submission strategy related items are maintained in compliance with EU CTR (e.g., study initiation dates etc)
- Supports non routine submission activities and deviation follow-up as needed (e.g., provision of Serious Breach submissions, submission of inspection reports, ad-hoc unexpected filings etc.)
- Supports process development/SOP related activities as requested.
- Support maintenance of EU CTR related training materials
- Supports oversight of EU-CTR team or sub-group to support allocation/reallocation of resourcing as needed within teams.
- Manages, plans, and executes regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle
**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:
- BSc. advanced scientific related degree preferred; BA accepted based on experience.Advanced degree preferred
- Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
- Solid working knowledge of regulations and guidelines govern
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