Sr. Manager, Eucan Regulatory Strategy Lead

vor 2 Wochen

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

-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
- 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 biol

  • Eucan Regulatory Manager

    Vor 4 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **EUCAN Regulatory Manager - Clinical Trials** in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** Under supervision from a senior team member and/or in collaboration with EUCAN Regulatory Lead: -...

  • Ass. Director, Regulatory Lead, Eucan

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Come join our team as Ass....

  • Ass. Director, Regulatory Lead, Eucan

    Vor 3 Tagen

    Zurich, Schweiz Takeda Vollzeit

    At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. - Come join our team as Ass....

  • (Associate) Director, Eucan Regulatory Lead, Gi

    vor 1 Woche

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a EUCAN Regulatory Lead GI in Switzerland. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: - Defines, develops and leads regional strategies to maximize regulatory approvals and patient access...

  • Associate Director, Eucan Regulatory Lead, Gi

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an** **Associate Director, EUCAN Regulatory Lead, GI in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: - Collaborates to define, develop and lead regional strategies to maximize...

  • Sr. Manager, Eu Regulatory Lead

    Vor 6 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **OBJECTIVE**: - Collaborates to define, develop and sometimes lead 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...

  • Associate Director, Eucan Regulatory Lead, Oncology

    vor 3 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **OBJECTIVE**: - Collaborates to define, develop and lead 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 strategic and tactical advice and guidance to...

  • Eucan Regulatory Affairs Manager, Oncology

    Vor 4 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **EUCAN Regulatory Affairs Manager, Oncology,** based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: - Provides regional strategic and tactical advice and guidance to teams to...

  • Commercial Quality Lead, Eucan

    vor 15 Stunden

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **About the role**: - You will perform the quality oversight of selected EUCAN LOCs as assigned by the EUCAN CQ Head. - Responsibilities cover in-country distribution quality, local MOH relationships, local quality surveillance and local contract manufacturing/packaging quality oversight. - You will drive the alignment of the strategies with the Quality...

  • Eucan Associate Regulatory Affairs Director

    vor 1 Woche

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **EUCAN Associate Regulatory Director - Clinical Trials**, based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: Provides supervision to junior team members to support / and...

  • Associate Director/ Director, Eucan Regulatory

    Vor 3 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a ** Director, EUCAN Regulatory Lead, Oncology** in Zurich, Switzerland. **Here, you will be a vital contributor to our inspiring, bold mission.** **Objective**: - Defines, develops and leads regional strategies to maximize regulatory...

  • Director, Eucan Regulatory Affairs Lead

    vor 1 Woche

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?** **OBJECTIVE**: - Effectively communicates the regulatory strategies, submission plans and timelines; assessment of the likelihood of success of the regulatory strategies and impact assessments of trends, regulations and changes related to...

  • Eucan Lead

    vor 1 Woche

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **About the role**: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join...

  • Eucan Strategic Initiatives Lead

    Vor 3 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as our EUCAN Strategic Initiatives Lead. Here, you will be a vital contributor to our inspiring, bold mission. As our successful EUCAN Strategic Initiatives Lead, you will develop and drive the (GREFP) EUCAN Strategy for Real Estate &...

  • Pdt Franchise Head, Eucan

    Vor 5 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovative-driven company, that will inspire you and empower you to shine? Join us as a **PDT Franchise Head, EUCAN**. **Here, you will be a vital contributor to our inspiring, bold mission.** The **PDT Franchise Head, EUCAN **leads priority workstreams for the Plasma Derived Therapies (PDT) franchise for EUCAN (Europe...

  • Talent Acquisition Eucan Lead

    vor 1 Woche

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?** Global Portfolio Division (GPD) is a newly formed business within Takeda, brought together to position Takeda’s future success by growing our global brands as well as supporting continued growth of our late-stage pipeline and driving...

  • Associate Director, Pv Vaccine Expert

    vor 3 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as an **Associate Director, PV Vaccine Expert - EUCAN** for our Vaccines Business Unit, based in Zurich, Switzerland. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: - Responsible for supporting...

  • Safety Manager

    Vor 5 Tagen

    Zurich, Schweiz SR Technics Vollzeit

    Your tasks - Coordinate Safety Management System activities and standardization initiatives worldwide - Support Leadership Team in design, implementation and maintenance of global Safety Management System strategy - Manage and continually improve the SR Technics SMS Manual, corresponding processes and work instructions - Develop, implement and maintain...

  • Eucan Pva Access Manager

    vor 3 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do **you have?** **Location: EUCAN - occasional on-site presence in Zurich will be required** **Job Overview**: - Drive market access initiatives across Europe and Canada region that ensure commercial success of predominantly Neuro-Science franchise in a...

  • Regional General Counsel Eucan

    Vor 3 Tagen

    Zurich, Schweiz Takeda Vollzeit

    **About the role**: **The Regional General Counsel, Europe & Canada (EUCAN RGC) is responsible for legal support and for managing legal risks relating to the Takeda European and Canadian operations in the framework of the global function, Global General Counsel (GGC). The Head of Legal EUCAN reports to the Global General Counsel.**: **The EUCAN RGC oversees...