Senior Manager, EU Regulatory Lead Neuroscience / Gastrointestinal-Inflammation

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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

About the role:
The Regulatory Affairs, Senior Manager is responsible for ensuring that the organization gains regulatory approval for new products and product amendments. This role also maintains the currency of product licenses and permits, ensuring compliance with legislation and regulations. By monitoring regulatory developments and implementing compliance programs, this position supports Takeda's mission.

OBJECTIVES/PURPOSE

• Collaborates to define, develop, and lead the Regional 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
• Collaborates 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 development of team members and provides direction, support, mentoring, and strategic guidance to fulfil scope of project work, when applicable.
• Leads (May lead or contribute to) the Submission Working Group and represents the region as needed on global and project teams.
• Supports interactions with health authorities in the region for an asset

SCOPE

• Geographical scope: Takeda EUCAN region

ACCOUNTABILITIES

• Demonstrates Takeda leadership behaviors and encourages the team to live up to the Takeda Code of Conduct and leadership behaviors
• Collaborates with Takeda Global, Regional counterparts, Local Regulatory Affairs, and Integrated Franchise Team (IFT) to manage all aspects of regulatory activities throughout the product life cycle. 
• May be regulatory lead or may support 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.
• Provides regulatory expertise on drug development, registration and / or post-marketing compliance and life cycle management and actively pursues the tracking and fulfilment of post marketing commitments.
• 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.
• A minimum of 6 years (4 years) of experience in drug regulatory affairs preferably within the EU region.
• Experience with advanced therapeutic medical products (Cell & gene therapy) will be advantageous
• Solid regulatory experience, including knowledge of regulations and guidance applicable in the region across all phases of development and able to orient project teams in the interpretation of guidelines; an understanding of basic regulatory requirements in other regions globally (US, EU, Emerging markets) is a plus.
• 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 and influence in cross-functional / global teams
• Promotes an inclusive culture and 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
• 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
• Travel Requirements
  • Requires Willingness to travel to various meetings, including overnight trips. approximately up to 10% travel.
• Physical Demands
  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Carrying, handling, and reaching for objects.
  • Ability to sit or stand for long periods of time while traveling.
• Work in flexible hours 

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