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Under supervision from a senior team member and/or in collaboration with EUCAN Regulatory Lead:
- Develops the operational implementation plan for clinical trial applications (CTAs) in European Region from initial submission throughout lifecycle, in alignment with the global submission strategy. This may concern trials across a variety of Therapeutic Areas, including oncology, rare disease, marketed products and neuroscience.
- 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.
- Identifying regional/national requirements to support submissions
- Ensuring all necessary documentation is made available for submission and internally approved as appropriate
- Coordinating submission preparations process and creation of administrative documents to support CTA filings or lifecycle activities (in collaboration with CROs where applicable)
- Ensuring 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)
- Providing 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)
- Supporting regulatory responses processes as requested by EUCAN Regulatory Lead
- Supporting 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:
- 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)
- 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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
- Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases
- Solid working knowledge of regulations and guidelines governing drugs and biologics in development, specifically focused on EU clinical trials.
- Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy
- Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region
- Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
- Able to understand broad concepts within regulatory affairs and implications across the organization and globally
- Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
- Generally strong in working well with others, within global teams and communicating with senior leadership
- Takes stand on important issues in productive, respectful way
Experience managing relationships with CROs and/or contractors also preferred