Senior Specialist, EUCAN Regulatory Lead - GI and inflammation

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Job Description

OBJECTIVES/PURPOSE:

• Provides support to senior team members to define, develop and lead the Regional (Europe & Canada [EUCAN] GI&I strategies to maximize regulatory success and strengthen the product development plan in support of enabling patient access, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management
• May collaborate with the global, regional, and local team to enable patient access in alignment with program objectives and timely approval of investigational applications and life-cycle management applications, while maintaining full compliance with applicable regulatory requirements. 
• Contributes to the Submission Working Group and represents the region as needed on global and project teams.
• Under the supervision of a senior team member and/or Line Manager, supports interactions with health authorities in the region for products within their responsibility.

ACCOUNTABILITIES:

• Demonstrates Takeda leadership behaviors and encourages the team to live up to the Takeda Code of Conduct and leadership behaviors
• Supports collaboration with Takeda Global, Regional counterparts, Local Regulatory Affairs, and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed in line with product team objectives.
• Supports a more senior regulatory lead for assigned assets and/or projects
• Effectively communicates the regulatory strategies, submission plans and timelines, probability of success, and impact assessments to assigned programs and presents regional regulatory strategies to leadership/senior management
• Stays current with regulations / guidance in the region and in coordination with local regulatory leads and Global Regulatory Policy & Innovation, provides strategic advice on emerging trends, regulations, and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.
• In alignment with line manager, may provide strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
• Prepares and maintains regulatory planning/filing documents for assigned products in the region.
• Participates, as appropriate, and authors/reviews internal procedures and processes. 
• Understands and interprets complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy. 
• Supports Access to Medicines initiatives to develop and implement innovative patient access strategies. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed  
• Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross- functional Teams; company’s consultants and Business Partners as required.
• Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility 

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BSc. Advanced scientific related degree preferred; BA accepted based on experience.
• Experience in drug regulatory affairs / within the pharmaceutical industry in the EU/GEM region is preferable.
• Some experience in managing filings
• Knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU/GEM region 
• Analyzes issues with attention to detail and makes reasoned recommendations
• Can speak up and influence in cross-functional / global teams
• Expresses empathy for others
• Practices active listening, encourages open dialogue, feedback, and diverse opinions
• Is able to carry out assigned activities within reasonable time. Applies the given prioritization framework with limited support
• Fluency in English
• TRAVEL REQUIREMENTS:
• Requires Willingness to travel to various meetings, including overnight trips. approximately up to 10% travel.

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