Regulatory Affairs Manager

vor 2 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.** 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 4 Tagen

    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...

  • Regulatory Affairs Manager

    Vor 4 Tagen

    Zurich, Schweiz CTC Resourcing Solutions Vollzeit

    **Senior Regulatory Manager - 4947 LBD** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking a **Regulatory Affairs Manager** for long term contract role based in **Zug, Switzerland**. **Main Responsibilities**: - Manages regulatory responsibilities associated with...

  • Eucan Regulatory Affairs Manager, Oncology

    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 **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...

  • Head Regulatory Affairs Emerging Markets

    vor 1 Woche

    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

    vor 2 Wochen

    Zurich, Schweiz Proclinical Vollzeit

    Our client a global pharmaceutical company specializing in rare diseases, Nephrology and Cardiorenal therapeutic areas is looking to appoint a Regulatory Affairs Labelling manager in their Zurich offices. This is an excellent opportunity to gain global experience within RA labelling in a high performing team at a time when multiple new drug development...

  • Regulatory Affairs Manager

    Vor 2 Tagen

    Zurich, Schweiz Akina Vollzeit

    Akina is a leading developer of medical software to empower patients during independent physiotherapy at home. With an AI-driven motion coach and unique entertainment integration, Akina addresses the lack of clinical feedback and motivation that causes 4 out of 5 patients to fail during self-care at home today. As a regulatory affairs manager at Akina, you...

  • Regulatory Affairs Manager Pharma Eu/ch

    Vor 6 Tagen

    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 2 Wochen

    Zurich, Schweiz Pfizer Vollzeit

    Regulatory Affairs Manager (M/F/d) 80-100% This is what you can look forward to: - Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background - Handling entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc. - Developing of submission...

  • 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...

  • Junior Regulatory Affairs Manager

    Vor 4 Tagen

    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...