Director, Eucan Regulatory Affairs Lead

vor 5 Monaten

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 assigned programs.
- Provides strategic and tactical advice and guidance and regional regulatory expertise to regional and global leadership teams on how to achieve timely and efficient conduct of all development and/or life-cycle management programs pertaining to the Therapeutic Area, while maintaining full compliance with applicable regulatory requirements
- Leads the Submission Working Group for submissions in the region and represents the region as needed on global and project teams.
- Manages/supports and oversees interactions with health authorities in the region
- Supports value and access team in their interactions with Health Technology Assessment (HTA) bodies for products within their responsibility.
- May act as the (deputy) Regional RA Therapeutic Area (TA) Team Lead.
- May provide leadership, mentoring and strategic guidance to regulatory strategists.

**ACCOUNTABILITIES**:

- Demonstrates Takeda leadership behaviors and encourages the team to live up to the Takeda Code of Conduct and leadership behaviors. Develops capabilities of staff members.
- Independently manages, plans, and works closely with Regional, LOC Regulatory Leads, BU Cross-functional Teams, and Global Regulatory Teams to direct all aspects of regulatory activities throughout the product life cycle.
- Presents regional regulatory strategies to leadership/senior management.
- Provides regulatory expertise to senior management on drug development, registration and / or post-marketing compliance and life cycle management.
- Evaluates new business development opportunities and / or participates on due diligence teams
- In coordination with local regulatory leads and Global Regulatory Policy & Innovation, provides strategic advice on emerging trends and regulations, and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.
- Actively pursues or oversees the tracking and fulfillment of post marketing commitments.
- Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy.
- Supports Access to Medicines initiatives to develop and implement innovative patient access strategies
- Drives the development of effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross
- functional Teams; company’s consultants and Business Partners as required.
- Proactively builds/strengthens external stakeholder (Regulatory Agency where applicable, external experts, industry organizations, etc.) contacts/influence to achieve Takeda strategic goals and objectives
- Effectively communicates the regulatory strategies, submission plans and timelines, probability of success, and impact assessments of trends, regulations and changes related to assigned programs.
- 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 the importance and oversees regulatory dossiers for value and access strategies and encourages the design of an integrated regulatory submission & access strategy in partnership with access functions as needed
- Leads, oversees and ensures preparation activities for meetings with Health Authorities for the assigned program, as required.
- Interacts directly with Health Authority and represents Takeda in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps
- Independently leads meetings and / or interactions with regional regulatory authorities or (in conjunction with LOC) national authorities and negotiates on behalf of project team as necessary.
- Contributes to ensure coverage for projects within the therapeutic area, identifies possible gaps, and proposes solutions to the management.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- BSc. Advanced scientific related degree with Regulatory Affairs focus preferred.
- A minimum of 10-15 years of experience in drug regulatory affairs including in global regulatory role and in Europe/International region.
- Solid regulatory experience, including knowledge of regulations and guidance applicable in the region across all phases of drug development and with the management of post-approval obligations and able to independently orient project teams in the interpretation of guidelines; including a good understanding of regulatory requirements globally and in other regions (US, EU, Emerging markets).
- Must have experience with the developme

  • Ass. Director, Regulatory Lead, Eucan

    vor 6 Monaten

    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....

  • Ass. Director, Regulatory Lead, Eucan

    vor 6 Monaten

    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....

  • Director Regulatory Affairs

    vor 4 Monaten

    Zurich, Schweiz Sonova Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...

  • Associate Director, Eucan Communications

    vor 4 Monaten

    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?** This position will be an integral part of the Regional External Affairs team. We are looking for a communications expert with a strong proven track-record delivering strategic communications activities. **_ OBJECTIVES_** - Strategic...

  • Associate Director Regulatory Affairs, Marketed

    vor 5 Monaten

    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 (Europe & Canada) Regulatory Affairs **Strategy Lead, Marketed Products **in our **Zurich** office. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: -...

  • Associate Director, Global Regulatory Affairs Cmc

    vor 5 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Global Regulatory Affairs CMC - Marketed Products in our Zurich office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an...

  • Associate Director, Global Regulatory Affairs Cmc

    vor 4 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Global Regulatory Affairs CMC - Marketed Products in our Zurich office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an...

  • Regulatory Affairs Manager

    vor 5 Monaten

    Zurich, Schweiz Sonova Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...

  • Associate Director Global Regulatory Affairs Cmc

    vor 5 Monaten

    Zurich, Schweiz Takeda Vollzeit

    Join Takeda as Associate Director, Global Regulatory Affairs CMC Established Products Inspired Collaboration (EPIC) Lead, where you are accountable for developing and executing on GRA CMC strategies for lifecycle management. You ensure global strategies are implemented across existing portfolio, while ensuring team effectiveness in a complex matrix...

  • Director, Global Regulatory Affairs Cmc Alliance

    vor 5 Monaten

    Zurich, Schweiz Takeda Vollzeit

    Join Takeda as Director, Global Regulatory Affairs CMC Alliance Partnered and Divested Product Lead, where you are accountable for developing and executing on GRA CMC strategies for lifecycle management. You ensure global strategies are implemented across existing portfolio, while ensuring team effectiveness in a complex matrix environment. Reporting to the...

  • Head Regulatory Affairs Emerging Markets

    vor 5 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic and visionary leader with a strong background in regulatory affairs within the...

  • Sr. Manager, Eu Regulatory Lead

    vor 5 Monaten

    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...

  • Manager, Clinical Trial Regulatory Lead

    vor 5 Monaten

    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 / Purpose_:_ _ - Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally (GEM and EUCAN region), in Europe through the EU Clinical Trial Information System (CTIS) or legacy...

  • Associate Director, Clinical Regulatory

    vor 4 Monaten

    Zurich, Schweiz Denali Therapeutics Vollzeit

    **Associate Director, Clinical Regulatory** Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. **The Opportunity** **Responsibilities** - Accountable for developing and implementing regulatory strategy for complex...

  • Pdt Franchise Head, Eucan

    vor 6 Monaten

    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...

  • Global Regulatory Affairs Labelling Manager

    vor 5 Monaten

    Zurich, Schweiz CSL Behring Vollzeit

    CSL Vifor is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent global position in the Global Regulatory Affairs Labelling team has arisen. Which can be based at any of our CSL R&D Hubs (Maidenhead UK, Amsterdam, NL, Bern, CH, Zurich, CH, KOP, PA or Waltham,...

  • Director, Cmc Regulatory Compliance

    vor 6 Monaten

    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. Join Takeda as a Director,...

  • Eucan Patient Value

    vor 5 Monaten

    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?** **_ OBJECTIVES/PURPOSE: _** - Provide a single point of contact for all PVA activities related to Rare Genetics & Hematology (RGH) within the EUCAN Region - Support Local Operating Companies (LOCs) with the planning and execution of Access &...

  • Eucan Patient Value

    vor 5 Monaten

    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?** **_ OBJECTIVES/PURPOSE: _** - Provide a single point of contact for all PVA activities related to Hereditary Angioedema (HAE) and Transplant disease areas within the EUCAN Region - Support Local Operating Companies (LOCs) with the planning...

  • Head of Regulatory Affairs and Sustainability

    vor 5 Monaten

    Zurich, Schweiz RAHN AG Vollzeit

    Founded in 1940, based in Switzerland and family-owned RAHN-Group is renowned for exceptional products and outstanding innovative solutions. We are internationally active on the market with specialty chemicals for EnergyCuring, with high-quality active ingredients and special products for the Cosmetic industry. Years of experience, know how and competent...