Associate Director Regulatory Affairs, Marketed

vor 2 Wochen

Zurich, Schweiz Takeda 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**:

- Collaborates to define, develop and lead regional strategies to maximize regulatory and patient access success to enable 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 teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
- Provide regulatory expertise for multiple projects and/or one highly complex project for assigned development project of responsibility.
- Mentors team members, if required, to support scope of project work.
- May be called upon to act as deputy to the regional therapeutic area lead and/ or Region regulatory head, attending internal leadership team meetings, as appropriate
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.
- For centralized products is the primary EMA contact for project(s)/products of responsibility or can delegate with oversight. Informs the business. Manages interactions with EMA and national health authorities (and HTAs jointly with value and access team in context of parallel consultation) in the Europe Union and European Economic Area for specific product(s).

**ACCOUNTABILITIES**:

- Leads the regulatory working team for Europe region submissions and represents as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan.
- Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
- For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
- Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility. Authors and reviews regional regulatory strategies as well as executes day-to-day activities for projects or may delegates oversight.
- Leads and manages meetings and / or interactions with regulatory authorities and agency meetings.
- Regulatory reviewer in due diligence for licensing opportunities, development and /or marketed product opportunities.
- Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives.
- Identifies regulatory requirements and trends across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas, as requested.
- Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
- Presents to senior management as requested.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- BSc degree or equivalent in science; advanced degree preferred
- A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience.
- Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
- Solid working knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in EU (A good understanding of basic regulatory requirements in emerging markets preferred. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
- Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Generally strong and independent skills in the area of regulatory strategy such as understan

  • Associate Director/ Director, Regulatory Affairs:

    vor 3 Wochen

    Zurich, Schweiz Novavax, Inc. Vollzeit

    If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases,...

  • Associate Director, Global Regulatory Affairs Cmc

    vor 3 Wochen

    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 6 Tagen

    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...

  • Director, Global Regulatory Affairs Cmc

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Join Takeda as a Director, Global Regulatory Affairs (GRA) CMC, where you will lead GRA CMC Due Diligence in partnership with organizational and external stakeholders. You will ensure the communication/development of regulatory CMC risks and strategy, develop best practices that enable CMC due diligence, ensuring that a given compound meets technical and...

  • Regulatory Affairs Manager

    Vor 2 Tagen

    Zurich, Schweiz Randstad Professionals Vollzeit

    For our client, an international pharmaceutical company, we are looking for a Regulatory Affairs Manager, Marketed Products Development, Growth and Emerging Markets (GEM). General Information: - Start date: ASAP - End date: 15.08.2025 - Workplace: Zurich - Department: Global Regulatory Affairs - Workload: 100% - Remote/Home Office: Possible About the...

  • Regulatory Affairs Manager

    vor 13 Stunden

    Zurich, Schweiz Randstad (Switzerland) Ltd. Vollzeit

    job details For our client, an international pharmaceutical company, we are looking for a Regulatory Affairs Manager, Marketed Products Development, Growth and Emerging Markets (GEM). General Information: - Start date: ASAP - End date: 15.08.2025 - Workplace: Zurich - Department: Global Regulatory Affairs - Workload: 100% - Remote/Home Office: Possible...

  • Director Regulatory Affairs

    vor 2 Wochen

    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, Regulatory Publishing and

    Vor 6 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 **Associate Director, Regulatory Publishing and Submission Management**. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVES/PURPOSE**:_ _ This key position is part of Global Regulatory Operation...

  • Associate Director Global Regulatory Affairs Cmc

    vor 2 Wochen

    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...

  • Head Regulatory Affairs Emerging Markets

    vor 3 Wochen

    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...

  • Associate Director, Clinical Regulatory

    vor 2 Wochen

    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...

  • Associate Director, Global Regulatory Affairs Cmc

    vor 4 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, Global Regulatory Affairs CMC** based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: - Responsible and accountable for regulatory CMC development,...

  • Regulatory Associate Director, Developent Strategy

    vor 1 Woche

    Zurich, Schweiz Alexion Pharmaceuticals,Inc. Vollzeit

    Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...

  • Associate Director

    vor 3 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Job Description **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**. Looking for an interesting role where you can develop your career, work at a growing...

  • Cmc Regulatory Affairs Associate Director Ch

    vor 3 Wochen

    Zurich, Schweiz NonStop Consulting Vollzeit

    If a chance to maximise the regulatory approvals with the use of your expertise and experience in RA sounds like something you would like to pursue, this position is for you! **Your responsibilities will be**: Establishing a coherent process and maintaining transparent communications between Global CMC and Regional Regulatory teams to enable CMC regulatory...

  • Director/associate Director, Eu Regulatory Lead

    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 a **Director/Associate Director, EU Regulatory Lead - Rare Genetic & Hematology** in our **Zurich **office. **Here, you will be a vital contributor to our inspiring, bold mission.** **Objective**: - Defines, develops and manages...

  • Associate Director/ Director, Eucan Regulatory

    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 ** 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...

  • Eucan Associate Regulatory Affairs Director

    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 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...

  • Director Global Regulatory Affairs, Rare Genetics

    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 a **Director Global Regulatory Affairs, Rare Genetics and Hematology - Gene Therapy** to be based in, based in either Zurich, Switzerland or Cambridge, Massachusetts, USA. **Here, you will be a vital contributor to our inspiring, bold...

  • Pfg Regulatory Affairs Lead

    vor 1 Woche

    Zurich, Schweiz Alexion Pharmaceuticals,Inc. Vollzeit

    Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...