Clinical Trial Regulatory Lead, Sr. Manager

vor 7 Monaten

Wien, Österreich Takeda Pharmaceutical Vollzeit

**ABOUT PLASMA-DERIVED THERAPIES**

As a trusted global leader and industry partner who is reimagining plasma and exploring its untapped potential, Takeda’s Plasma-Derived Therapies Business Unit is dedicated to transforming the lives of patients worldwide who rely on these lifesaving and life-sustaining therapies.

With an 80-year legacy of developing treatments for rare and complex chronic diseases, we thrive on innovation, offering a broad, differentiated portfolio of more than 20 plasma medicines with integrated care solutions to patients in more than 80 countries.

Powered by 17,000+ Takeda employees primarily focused on plasma, our > 200 high-quality BioLife donation centers, a dedicated R&D team, and eight world-class plasma manufacturing facilities, we are unleashing data, digital and technology to transform our end-to-end operations and set new industry standards.

This enables us to innovatively and sustainably meet the growing and changing needs of patients, our people, and our planet, today and in the future.

**THE OPPORTUNITY**

The position of **Clinical Trial Regulatory Lead, Sr. Manager** is a vital role within Takeda’s Plasma-Derived Therapies Function in the Global Regulatory Affairs department and works under the direction of the Team Lead EUCAN Regulatory Affairs. This role will cover CTRL responsibility as well as acting as EUCAN Regulatory Lead (EURL).

**Clinical Trial Regulatory Lead (70%)**:

- Develops the operational implementation plan for Clinical Trial Applications (CTAs) in EUCAN and GEM region from initial submission throughout lifecycle, in alignment with the global sub-mission strategy and the cross-functional team
- Oversees all activities related to the creation, submission, and maintenance of CTAs 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 compliance

**EUCAN Regulatory Lead (30%)**:

- Responsible for proactive development and implementation of regulatory strategies, objectives and policies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the European Union, Canada, Great Britain, Switzerland, South-Eastern Europe, Israel, and Palestine
- Represents EU RA Strategy at internal and external stakeholders
- Serves as a liaison to the European Medicines Agency (EMA) and National Competent Authorities and providing support for local Regulatory Affairs teams

Here you will help Takeda realize our ambition to transform the lives of patients through innovation and sustainability from plasma donation to delivery of medicines.

This is turn empowers Takeda’s unwavering commitment to patients.

**YOUR TASKS IN DETAIL**

**Clinical Trial Regulatory Lead**:

- Identifying regional/national requirements to support submissions, in collaboration with the CRO.
- 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 to ensure CTA aligns with Takeda expectations, communication cascade of approval notification of IB etc.)
- Providing global 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 Global 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.
- Works as part of team to provide proactive solutions to problems arising during the CTA processes in conjunction with Global 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

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