Manager/Senior Manager, EUCAN Regulatory Lead, Oncology応募後で応募 求人ID R0056452 掲載日 02/08/2022 Location:Zurich, Switzerland
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, EUCAN Regulatory Lead, Oncology in our Zurich office.
Here, you will be a vital contributor to our inspiring, bold mission.
- Under supervision from a senior team member and/or Line Manager defines, develops and leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives
- Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
- Leads the Regional Working Team and represents the region as needed on global and project teams
- Provides regional regulatory expertise for assigned development and /or life cycle management projects.
- Under supervision from a senior team member and/or Line Manager sometimes manages interactions withEMAand national health authorities (and HTAs in context of parallel consultation) in the European Region for product(s).
- 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 within scope and ensures timely approvals throughout product development and lifecycle
- Partners with the regional market access and local regulatory 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
- Partners with Takeda Global and Regional counterparts and Integrated Franchise Team to ensure the regional regulatory strategy is created and executed upon for all projects
- Identifies relevant regional regulatory requirements and trends, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to area and region of responsibility
- Develops and maintains effective working relationships withEUCAN regulatory and Oncology Team members, local regulatory teams, Global Regulatory Teams, Cross-functional Teams; consultants and business partners
- Works with other regulatory affairs functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule.
- Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed
- 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, manages meetings and / or interactions with regulatory authorities and agency meetings; in alignment with line manager can negotiate on behalf of project team as necessary.
- 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
- Provides regional regulatory input in due diligence for licensing opportunities, development and /or marketed products as required.
- Pro-actively 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 in these areas
- Ensures coverage for projects within the therapeutic area identifies possible gaps, and proposes solutions to the management
- BSc. Advanced scientific related degree preferred; BA accepted based onexperience.
- Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and 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) of scope as it relates to regulatory requirements and strategy
- Experience in managing multiple filings; or managing multiple programs in closely related development area is preferred; expertise in the EU region with global involvement also preferred
- Knowledge of 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 with senior leadership.
- Takes stand on important issues in productive, respectful way.
- Experience managing relationships with CROs and/or contractors also preferred.
WHAT TAKEDA CAN OFFER 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 Future to people around the world.
Empowering Our People to Shine
Discover more at takedajobs.com
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, colour, 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?