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Senior Manager, EUCAN Regulatory Lead, Marketed Products
- Ensures regional regulatory strategies are written, reviewed and executed according to plan
- In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
- Manages, plans, and executes regional regulatory submissions and ensures timely approvals throughout product development and lifecycle
- Partners with the regional market access and local regulatory affairs colleagues to define the strategy for, and to oversee joint interaction with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making
- Partners with Takeda Global and Regional counterparts and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed upon for all projects within area of scope
- Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
- Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on a timely manner
- In partnership with global colleagues, works to resolve regional critical conflicts in global regulatory strategies.
- Under supervision from a senior team member and/or Line Manager, represents Takeda in Health Authority meetings, as required. Effectively conveys and manages meeting outcome and next steps
- Lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products, as needed
- Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support Takeda strategic goals and objectives
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team and /or higher governance bodies
- Ensures coverage for projects within the therapeutic area identifies possible gaps, and proposes solutions to the management
- BSc. Advanced scientific related degree. Advanced degree would be preferred
- Experience within the pharmaceutical industry and including directexperience in regulatory affairs in development and /or post-marketing phases.
- Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU
- Ability to interpret complex scientific issues across projects and therapeutic area(s) as it relates to regulatory requirements and strategy
- Experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region with global involvement would be preferred
- Excellent oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
- Ability to understand broad concepts within regulatory affairs and implications across the organization and globally
- Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Generally strong in working well with others, within global teams and communicating with senior leadership
- Experiencein managing relationships with CROs and/or contractors also preferred.
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.