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

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