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.
We are currently seeking a Manager/Senior Manager to join Takeda's Oncology team as the EUCAN Regulatory Lead. This role is crucial for our growing oncology portfolio, where you will collaborate to lead and execute the regulatory strategy for our assets within the EUCAN region. Additionally, you will manage all necessary regulatory activities through to approval and subsequent life-cycle management, ensuring that we meet our goals and deliver innovative therapies to patients in need. Additionally, you will manage all necessary regulatory activities through to approval and subsequent life-cycle management, ensuring that we meet our goals and deliver innovative therapies to patients in need.
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 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.
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 of experience in drug regulatory affairs preferably within the EU/GEM 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
Locations
Zurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
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What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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