Regulatory Affairs Manager

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

**We are currently hiring for a Regulatory Affairs Manager **(all genders) in full-time on a permanent contract for our Swiss local office in Glattpark (Opfikon).**:
**Your tasks in detail**:

- Manage **MA lifecycle maintenance** for a defined product portfolio, inclusive local impact assessments of global changes, preparation, and filing of renewals, variations (CMC and non-CMC), labeling updates, PSUR/PBRERs etc. to ensure national registrations and comply with Swiss local requirements.
- Ensure **compliance of labelling** (and mock-ups) with the CCDSs and manage communication to internal and external stakeholders as applicable to ensure timely implementation
- Contact for the assigned products towards Swissmedic and respond within required Deadlines to Swiss Authorities
- Represent Regulatory Affairs for the defined product portfolio in internal cross-functional meetings and projects
- Support QA department for product releases
- Maintain **global and local regulatory databases** and systems to ensure accurate records of regulatory activities and documentation
- Review **promotional and educational materials** for the assigned product portfolio
- Contribute to Regulatory Intelligence and assess impact on local business and products

**Your profile**:

- University degree in Pharmacy or other scientific studies
- Minimum 2 years’ experience in Regulatory Affairs, within a pharmaceutical company. CRO, similar organization in Switzerland or Swissmedic
- Advanced knowledge of applicable Swiss laws, regulations, and codices for pharmaceutical industry in Switzerland
- Business fluency in German and English (speaking and writing)
- Cross-functional mindset: Strong communicator with the ability to engage both external and internal customers

**Desirable additional skills**:

- Additional national language is a plus (French/ Italian)

**Empowering our people to shine**

**Diversity, Equity and Inclusion**

**Locations**:
CHE - Glattpark (Opfikon) - Zurich HQ

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

  • 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...

  • Global Regulatory Affairs Labelling Manager

    vor 6 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,...

  • Project Manager Global Affairs

    vor 5 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...

  • 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...

  • Regulatory Affairs Manager Pharma Eu/ch

    vor 5 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...

  • Junior Regulatory Affairs Manager

    vor 6 Monaten

    Zurich, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • 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...

  • 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...

  • 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 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...

  • Clinical Affairs Manager

    vor 6 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 Regulatory Affairs, Marketed

    vor 6 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**: -...

  • Clinical Affairs Manager

    vor 6 Monaten

    Zurich, Schweiz Sonova AG Vollzeit

    Who we are In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we - through our core business brands Phonak, Unitron, Sennheiser, Advanced...

  • Head of Integrity and Regulatory Affairs

    vor 6 Monaten

    Zurich, Schweiz ABB Vollzeit

    **Head of Integrity and Regulatory affairs**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations....

  • Regulatory Manager

    vor 5 Monaten

    Zurich, Schweiz FE fundinfo Vollzeit

    FE fundinfo is a global leader in investment fund data and technology and we are currently recruiting for a Regulatory Manager to join our team in Zurich (hybrid working). As a Regulatory Manager, you are tasked with driving the offerings the company has as a result of new or existing regulations. You will hold a fundamental position with key influence to...

  • 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...

  • Manager Regulatory Reporting

    vor 5 Monaten

    Zurich, Schweiz coni+partner AG Vollzeit

    Our client is an international bank in Zurich. We are looking for an accounting specialist in fund business (m, f, d) as a Manager Regulatory Reporting Tasks Contribute to regulatory investment reportings for investors and authorities / Responsible for controlling transaction risks (minimization), transparency (SFDR), data quality and fast access to data...

  • 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...

  • Director, Cmc Regulatory Compliance

    vor 7 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,...

  • Quality Assurance Manager

    vor 6 Monaten

    Zurich, Schweiz Panda International Vollzeit

    **Quality Assurance Manager**: **Location** - Zurich, Switzerland **Business Sector** - Biotechnology **Job ref** - 22230 **Published** - 7 days ago **QA Systems Manager - Nordschweiz** Schließen Sie sich unserem Klienten in der Nordschweiz bei einer führenden Auftragsfertigungsorganisation (CMO) im Bereich Zell - und Gentherapie an. Wir suchen einen...