EUCAN (Associate) Director, Regulatory Lead, Rare Genetic & Hematology

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the EUCAN (Associate) Director, Regulatory Lead, Rare Genetic & Hematology in our Zurich office.

Here, you will be a vital contributor to our inspiring, bold mission.

As the EUCAN (Associate) Director, Regulatory Lead, Rare Genetic & Hematology you will be empowered to define, develop and direct regional strategies to maximize regulatory approvals and patient access to meaningful medicines.

• Effectively conveys assessments of the likelihood of success of these regulatory strategies.
• Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs
• Directs the Regional Working Team and represents the region on global and project teams.
• Provides regional regulatory expertise for assigned development and life cycle management projects
• Manages and oversees interactions with EMA and national health authorities (and HTAs jointly with value and access team in context of parallel consultation) in the European Region
• Ensures regional regulatory strategies are written, reviewed, and executed
• Authors and oversees execution for more complex regional regulatory strategies
• Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs
• Manages, plans, and executes regional regulatory submissions within the area of duty and ensures timely approvals throughout product lifecycles.
• Partners with the regional market access and local regulatory colleagues to define the strategy for, and to steer joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to help heath authority decision making
• Partners with Global and Regional counterparts and Integrated Franchise Team to ensure the regional regulatory strategy is created and executed upon
• Identifies regulations and trends across scope of remit, and provides regulatory guidance, and expertise to global development team and higher governance bodies in these areas
• Mentors team members
• May be called upon to act as deputy to the regional regulatory head.

Qualifications

• Relevant education with an advanced science BSc or higher degree being advantageous
• Extensive pharmaceutical industry career, in regulatory or a solid combination of regulatory and both development or post-marketing phases.
• Solid working knowledge of regulations and guidelines governing drugs and biologics in all phases of development, including post-marketing, in Europe, with also preferably in emerging markets.
• Understanding of evidence requirements beyond the regulators (e.g. HTA bodies).
• Understands and interprets complex scientific issues across projects and therapeutic area of remit as it relates to regulatory requirements and strategy
• Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region with global involvement also preferred.

What Takeda can do for you

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 Futureto people around the world.

Empowering Our People to Shine

Discover more at takedajobs.com

At our heart are dedicated 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, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

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