Senior Manager- EUCAN Regulatory LOC Liaison

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Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

Objective:

The Regional Regulatory Liaison plays a pivotal role in facilitating communication, coordination, and alignment within the Affiliate Regulatory Community across the Europe and Canada (EUCAN) region. This role serves as a key point of contact between regional affiliates, global regulatory functions, and cross-functional teams, ensuring seamless information flow and collaboration.

How you will contribute

• Contribute to build and enhance EUCAN LOC (Local Operating Company- Affiliate) regulatory community through participating and/or leading meetings, forums, and working groups
• Build strong partnership with Local Regulatory Affairs (LOC RA) network in the Region to help identify risks and trends impacting Regulatory Affairs in the region and facilitate best practice sharing
• Support and help drive Global and Regional Regulatory initiatives to ensure regulatory compliance in the Region
• Aid in the introduction, implementation and optimization of relevant tools and processes, in particular in the digital space.
• Flag local regulatory issues, ensure appropriate communication and help implementing/executing the global/Regional strategy

Accountabilities:

• Contribute to build a strong understanding of LOC RA operating models and capabilities, to better assess the impact of any GRA or EUCAN regulatory changes on LOC RA systems and processes
• Ensure list of LOC RA contacts are kept up to date according to agreed process and manage common accessible platform for the sharing of EUCAN LOC and Regional RA tools and information
• Contribute to proactively builds/strengthens internal (i.e. LOC RAs) and external stakeholder relationships to achieve Takeda strategic goals and objectives within the EUCAN Region.
• Provide support to the maintenance of formal channels of communication and interaction with LOC RAs, co-creating meeting agenda for Regional RA internal conferences with Global R&D and EUCAN commercial stakeholders.
• Contribute to facilitate best practice sharing between LOC RAs and between LOC RAs and
• Regional RA/GRA and, aid introduction of relevant tools and processes for regulatory knowledge and information exchange between LOCs and between LOCs and global/Regional RA
• Help identify issues and escalate them appropriately.
• Represent EUCAN LOC Liaison Lead in meetings, when appropriate
• Maintain awareness of the Regulatory environment and emerging trends
• Demonstrates Takeda leadership behaviors and encourages the team to live up to the Takeda Code of Conduct and leadership behaviors

Education & Competencies:

• BSc. Advanced scientific related degree preferred
• A minimum of 3 years of experience in the pharmaceutical industry preferably in Regulatory Affairs within the EU/GEM region.
• Basic knowledge with the regulations for the pre- and post-marketing global environment and European legislation and procedures
• Agile with digital tools
• Is able to prioritize activities and execute within reasonable time with limited supervision.
• Adapts to changing circumstances and is proactive
• Good networking and relationship building skills
• Good communication skills in an international environment. Communicates in concise and respectful manner across different cultures
• Enables information sharing, helps groups to understand each other while practicing active listening. Encourages open dialogue, feedback, and diverse opinions
• Analyzes issues with attention to detail and makes reasoned recommendations based on evaluation of alternative approaches
• Receive feedback from manager and give feedback to peers; 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 (other languages are a plus)

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