By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

　　Job Description

　　Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Sr. Manager, EUCAN Regulatory Strategy Lead in our Zurich office.

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

　　OBJECTIVE:

　　Under supervision from a senior team member and/or Line Manager defines, develops and sometimes leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives

　　Effectively communicates objective assessments of the likelihood of success of these regulatory strategies

　　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

　　s 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 within the therapeutic area of responsibility

　　Under supervision from a senior team member and/or Line Manager sometimes manages interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the European Region for product(s) within their responsibility.

　　ACCOUNTABILITIES:

　　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 the area of responsibility and ensures timely approvals throughout product development and lifecycle

　　Partners with the regional 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 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 responsibility

　　Identifies relevant regional 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

　　Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to area and region of responsibility

　　May be called upon to provide direction to senior leadership, as relevant

　　Develops and maintains effective working relationships with EUCAN RA and Marketed Product Team members, LOC RA teams, Global Regulatory Teams, Cross-functional Teams; consultants and business partners as required

　　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 as needed

　　In collaboration with global colleagues, works to resolve regional critical conflicts in global regulatory strategies.

　　Authors and oversees execution for more complex regional regulatory strategies as needed

　　Under supervision from a senior team member and/or Line Manager, sometimes leads and 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, sometimes represents Takeda in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps

　　May be required to lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products

　　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 across 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 projects within the therapeutic area identifies possible gaps, and proposes solutions to the managementPresents regional regulatory strategies to senior management as applicable

　　EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

　　BSc. Advanced scientific related degree preferred; BA accepted based on experience.Advanced degree preferred

　　Considerable experience within the pharmaceutical industry and including direct experience 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

　　Understands and interprets complex scientific issues across projects and therapeutic 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 the EU 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

　　Able 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.

　　Takes stand on important issues in productive, respectful way.

　　Experience managing relationships with CROs and/or contractors also preferred.

　　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?

　　Locations

　　Zurich, Switzerland

　　Worker Type

　　Employee

　　Worker Sub-Type

　　Regular

　　Time Type

　　Full time