Director, Regulatory Affairs Strategy Lead - Rare Diseases - EUCAN
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
What makes a successful member of our team?
We take action and make decisions by focusing on our four priorities in this order:
Putting the patient
at the center
Life at Takeda
To keep delivering new value to patients, we provide growth opportunities for every employee according to their abilities and passions, and together are building a stronger organization.
Procurement Lead, Northern Europe
“Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”
Regional Head, Europe, Vaccines
“Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
Director, Regulatory Affairs Strategy Lead - Rare Diseases - EUCANApply Now
Director, Regulatory Affairs Strategy Lead - Rare Diseases (EUCAN - Europe & Canada)
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Regulatory Affairs Strategy Lead - Rare Diseases in our Switzerland office.
Here, you will be a vital contributor to our inspiring, bold mission.
The Regulatory Affairs Strategy Lead – Rare Diseases defines, develops and leads regional strategies to maximise regulatory and patient access success to enable patient access to meaningful medicines in alignment with program objectives. A typical day will include:
- Ensure global/regional regulatory strategies are written, reviewed and executed according to plan and appropriately capture patient access requirements. Usually has own Regulatory lead role. 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.
- Partner with the regional/LOC market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making.
- Collaborates with Takeda counterparts and IBT to ensure a regional regulatory strategy is created and executed upon for all projects within area of responsibility. Identifies regulatory requirements and trends across scope of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
- Directs and oversees multiple projects, generally has regional oversight for compounds in a minimum of one disease area.
- Oversees and 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. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
- In collaboration with global colleagues, works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables outside of region as agreed within the global regulatory strategy. Approves regional regulatory strategies and authors for more complex regulatory strategies as needed; oversee execution, generally delegates to staff and / or vendor.
- Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; negotiates on behalf of project team as necessary.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organisations, etc) contacts/influence to achieve Takeda strategic goals and objectives.
- Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
- Ensures coverage for project and therapy area(s) responsibilities; Elevates needs when necessary
- BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
- Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases.
- Solid working knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role), with a good understanding of basic regulatory requirements in emerging markets. Understanding of evidence requirements beyond the regulators (e.g. HTA bodies)
- Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility 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 either EU or US region (as relevant to role) with global involvement also preferred.
- Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organisation 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.
- Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
- Experience in managing personnel required; experience 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 realise 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.
Empowering Our People toShine
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Job ID SR0042985