Director, Global Regulatory Affairs Cmc Alliance

vor 7 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 of GRA CMC for MPD, CMC Sourcing and Due Diligence, you partner closely across the organization to influence as a key opinion leader within Takeda, providing consistent messaging on Takeda’s scope of regulatory within the Contract Manufacturing Business (CMB) for downstream efficiency proceeding complexity of divestment decisions, and align on ways of working for Takeda alliance partnered products.

**How you will contribute**:

- Evaluate change proposals for global regulatory impact and plan global variations and amendments.
- Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
- Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and review content for conformance with established requirement.
- Ensures project team, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Provide solutions to prevent recurrence of issues.
- Interact directly with international Health Authorities. Participate in and facilitate agency meetings.
- Maintain constructive relations with essential colleagues, e.g., colleagues within Takeda, Alliance Partners, and Health Authority representatives.

What you bring to Takeda:

- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
- Experience with active pharmaceutical ingredient/drug substances, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products is required.
- Expert in developing alternate strategies based on guidance/regulations.
- Expert in liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings. International experience preferred.
- Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Able to provide sound strategic advice and enable critical decisions under ambiguity.
- Demonstrate leadership, problem-solving ability, flexibility, and values teamwork.
- Demonstrate strategic enterprise thinking, with the ability to influence at all levels in a complex matrix environment.
- Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
- Good judgement in elevating and communicating actual or potential issues to line management.
- Builds and maintains a team environment that inspires and enables people to move the organization forward.
- Expert in CTD authoring and/or review skills throughout the product lifecycle, with a solid understanding of global submission complexities.

Travel Requirements:

- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.

**Locations**:
Zurich, Switzerland

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

  • Associate Director, Global Regulatory Affairs Cmc

    vor 7 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 6 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 7 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, Cmc Regulatory Compliance

    vor 9 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,...

  • Cmc Regulatory Affairs Associate Director Ch

    Vor 7 Tagen

    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 Global Regulatory Affairs, Rare Genetics

    Vor 7 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 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...

  • Project Manager Global Affairs

    vor 6 Monaten

    Zurich, Schweiz Global Affairs Vollzeit

    Global Affairs_ **Project Manager Global Affairs (m/w/d)** **80 % **:Die Abteilung Global Affairs der Universität Zürich (UZH) fördert und pflegt die weltweite Zusammenarbeit der Universität mit Partnerhochschulen und Institutionen in der internationalen (bildungs-)politischen Landschaft und im akademischen Umfeld mit dem Ziel, die internationale...

  • Director Regulatory Affairs

    vor 7 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...

  • Una Europa Project Coordinator

    Vor 5 Tagen

    Zurich, Schweiz Global Affairs Vollzeit

    _Global Affairs_ **Una Europa Project Coordinator** **100 %**:UZH Global Affairs strengthens the university's global network and collaboration with partner institutions and international stakeholders with the aim to enhance our impact and visibility around the world. Our team coordinates the implementation of the Global Strategy 2030 across the university...

  • Regulatory Affairs Manager

    vor 7 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.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do...

  • Global Regulatory Affairs Labelling Manager

    vor 7 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,...

  • Head of Regulatory Affairs

    Vor 4 Tagen

    Zurich, Schweiz Global Kader Personal Vollzeit

    **INTRODUCTION**: - For our client, a Swiss pioneer in ESG data science located in Zurich, we are looking for an individual as **Head of Regulatory Affairs**: - (Full time, unlimited contract) The earliest start date is as soon as possible. **ASSIGNMENT DESCRIPTION**: - Define a regulatory affairs strategy and articulate a business plan, including...

  • Executive Director, Regulatory Affairs

    Vor 7 Tagen

    Zurich, Schweiz Clinipace Vollzeit

    Clinipace is a mid-sized, global CRO, with a focus on performing quality work, recognising merit, and developing our employees. Whichever of our departments you join, you are helping to improve the lives of people globally, by contributing to the development of new medications and devices, and thereby helping solve the healthcare challenges that affect us...

  • Director, Eucan Regulatory Affairs Lead

    vor 7 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...

  • Associate Director Regulatory Affairs, Marketed

    vor 7 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**: -...

  • Gra Cmc Lead for Small Molecules and Complex

    vor 7 Monaten

    Zurich, Schweiz CSL Behring Vollzeit

    CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better,...

  • Regulatory Affairs Manager Pharma Eu/ch

    vor 7 Monaten

    Zurich, Schweiz Bernwald Personalberatung Vollzeit

    Unsere Mandantin ist ein Schweizer KMU, das sich in einer Nische im Pharmabereich erfolgreich etabliert hat. - In ihrem Auftrag suchen wir eine Persönlichkeit mit ausgeprägtem Verantwortungsbewusstsein als Regulatory Affairs Manager Pharma EU/CH (m/w/d). **IHRE AUFGABEN**: - Selbständiges Erstellen von CMC-Zulassungsdokumentationen - Termingerechte...

  • Regulatory Affairs Manager

    vor 7 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...

  • Global Communication

    vor 7 Monaten

    Zurich, Schweiz Global Affairs Vollzeit

    Global Affairs_ **Global Communication & Project Manager (M/F/d)** **80-100 % **:At the Global Affairs Office at the University of Zurich (UZH), we promote and maintain the university's worldwide collaboration with partner universities and institutions within the international educational and political landscape, as well as the academic community. Our goal...

  • Head Regulatory Affairs Emerging Markets

    vor 7 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...