Regulatory Affairs Manager

Vor 5 Tagen


Zurich, Schweiz Takeda Pharmaceutical Vollzeit

**SUMMARY**

Responsible for
- **
Regulatory Affairs**
Obtain and maintain marketing authorizations for products and communication of general regulatory requirements in support of licensing of Takeda’s products
**TASKS AND RESPONSIBILITES**
- 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.
- Applications for new **Marketing Authorization and line extensions** in collaboration with global and local functions as eCTD Format to Swissmedic
- 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 LOC QA Switzerland 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
- Striving for a performance-based culture and deliver operational excellence working in a cross-functional environment within R&D and the Commercial business based on the company’s values of Patient, Trust, Reputation and Business.
**Requirements (Education/Experience)**
- University degree in Pharmacy or other scientific studies
- Minimum 2-5 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
- Fluent written & spoken German & English / additional national language is a plus (French / Italian)
- Cross-functional mindset: Strong communicator with the ability to engage both external and internal customers
- Growth mindset: Strong ability to assimilate information (technical, regulatory, scientific) and discuss the relevance and impact on the assigned product portfolio and/or Marketing Authorization Applications
- Readiness to adapt to changing situations and drive necessary adaptations

SKILLS
- Computer Skills: Word, Excel, working with Databases (RA)
- French, Italian would be an advantage

**Locations**:
CHE - Switzerland - Commercial
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time



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