Manager, International Clinical Trial Regulatory Lead

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Job Description

Objective / Purpose:

• Contributes to the development of regulatory strategy for assigned clinical trials in Europe & Canada (EUCAN) and Growth & Emerging Markets (GEM) regions.
• Develops the operational implementation plan for clinical trial applications (CTAs) in EUCAN and GEM regions from initial submission throughout lifecycle, in alignment with the global submission strategy. This may concern trials across a variety of Therapeutic Areas, including oncology, gastrointestinal and inflammation, marketed products and neuroscience.
• Executes or oversees all activities related to the creation, submission, management of Requests for Information (RFI) and maintenance of CTAs Globally (GEM and EUCAN region) 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/or tracks CTA activities and eTMF updates performed by the International CTRL/CRO Regulatory Lead.  Works in collaboration with CRO to ensure Takeda compliance when appropriate.
• Responsible for the generation, maintenance and provision of metrics on workload as well as KPIs for key CTA activities and analyze consolidated data.
• Oversees CTA interactions with health authorities in the region during assessment of clinical trial applications.

Accountabilities:

• Demonstrates Takeda leadership behaviors.
• Collaborates with Takeda Global and Regional counterparts, as applicable to manage all aspects of assigned CTA regulatory activities throughout the development lifecycle.
• May present regional CTA regulatory strategies to leadership/senior management
• Identifies regional/national requirements to support submissions of CTAs to Regulatory Authorities.
• Coordinates submission preparations process and creation of administrative documents to support initial CTAs and/or maintenance submissions for the assigned interventional trials (in collaboration with CROs where applicable), ensuring all necessary documentation is made available for submission and internally approved as appropriate.
• Coordinates submission preparations process and creation of administrative documents to support initial Non-Interventional Post-authorisation safety studies (PASS) and/or maintenance submissions (in collaboration with CROs where applicable), ensuring all necessary documentation is made available for submission and internally approved as appropriate.
• Develops and maintains standardized communication/tracking/planning tools and templates for internal use.
• Ensures accurate and timely submissions and proactive communication of key regulatory milestones throughout clinical trial lifecycle (e.g., submission and approval of initial CTA, amendment/modification, HA questions/responses etc.).
• Provides regulatory oversight of CRO activities as applicable to ensure that all submissions activities are tracked, and appropriate systems are maintained in a compliant manner (e.g., eTMF).
• 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.).
• 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 senior team member and/or Global/EU Regulatory Lead, as applicable.
• Contribute to the maintenance of appropriate internal regulatory knowledge database on emerging information and trends with regulators for clinical trials.
• Participates in review of internal procedures and processes, as appropriate.  
• Ensures all information and documentation for submission to the EMA Clinical Trial Information System (CTIS) are completed and performed on a timely and compliant basis.
• Coordinates submissions in the CTIS portal.
• May represent Team in Workshop/cross functional initiatives related to clinical trials.
• Actively include participation of Local Operating Company Regulatory Affairs (LOC RA) in HA interactions related to CTA.

Education & Competencies (Technical and Behavioral):

• BSc. Advanced scientific related degree preferred; BA accepted based on experience. 
• A minimum of 3 years of experience in drug regulatory affairs preferably within the EU/GEM region.
• Experience with EU CTR will be advantageous.
• Solid regulatory experience, including knowledge of CTA regulations and guidance governing drugs and biologics in all phases of development for [Emerging markets and/or EUCAN Markets (relevant to role)].
• Has basic regulatory procedure knowledge with major health authorities in the region.
• Analyzes issues with attention to detail and makes reasoned recommendations.
• Can speak up.
• Promotes an inclusive culture and expresses empathy for others.
• Is able to carry out assigned activities within reasonable time.
• Adapts to changing circumstances and is able to build and maintain relationships.
• Receives and gives feedback; expresses ideas, questions, and disagreement.
• Is self-aware and able to function effectively while meeting the multiple challenges of daily life with a sense of energy, vitality, and confidence.
• Fluency in English.

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