Logo of Huzzle

Home

Matches

Explore

Manage

Regulatory Affairs Manager (all genders)

image

Takeda

3d ago

  • Job
    Full-time
    Junior, Mid & Senior Level
  • Healthcare
  • Zürich

AI generated summary

  • You have a degree in Pharmacy or science, 2–5 years in Regulatory Affairs, fluent in German and English, strong communicator, and adaptability to change with knowledge of Swiss regulations.
  • You will manage MA lifecycle maintenance, ensure compliance, handle submissions to Swissmedic, review materials, support QA, maintain databases, and represent Regulatory Affairs in cross-functional meetings.

Requirements

  • 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
  • Business fluency in German and English (speaking and writing)
  • 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

Responsibilities

  • Manage MA lifecycle maintenance for a defined product portfolio, including 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-/ indication 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.

FAQs

What is the job title for this position?

The job title is Regulatory Affairs Manager (all genders).

Where is the office located for this position?

The office is located in Glattpark (Opfikon), Zurich, Switzerland.

What are the required qualifications for this position?

A university degree in Pharmacy or other scientific studies is required, along with a minimum of 2-5 years' experience in Regulatory Affairs within a pharmaceutical company, CRO, or related organization in Switzerland or Swissmedic.

What language skills are necessary for this role?

Business fluency in German and English (speaking and writing) is necessary. Additional knowledge of French or Italian is a plus.

What types of tasks will I be responsible for in this role?

Responsibilities include managing MA lifecycle maintenance, applications for new Marketing Authorizations, ensuring compliance of labeling, maintaining regulatory databases, reviewing promotional materials, and representing Regulatory Affairs in internal cross-functional meetings.

What is the work schedule or time type for this position?

The work schedule is flexible, with a time type of 80-100%.

Is there an emphasis on company culture at Takeda?

Yes, Takeda emphasizes a performance-based culture, operational excellence, and the values of Patient, Trust, Reputation, and Business.

How does Takeda approach diversity, equity, and inclusion?

Takeda is committed to diversity, equity, and inclusion, welcoming candidates of any gender, age, religious belief, race or ethnic origin, or disability, based on merit.

What additional skills are considered desirable for this position?

Additional national language skills, particularly in French or Italian, are considered a plus for this role.

How can I apply for this job?

You can apply for this opportunity via Takeda's online application tool.

image

Takeda

Better Health, Brighter Future

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society. We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities.