Regulatory Affairs Manager

vor 2 Wochen

Zürich, Schweiz Takeda Vollzeit

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

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) on a permanent contract for our Swiss local office in Glattpark (Opfikon).

Your tasks in detail:

  1. 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.
  2. Applications for new Marketing Authorization and line-/ indication extensions in collaboration with global and local functions as eCTD Format to Swissmedic.
  3. Ensure compliance of labelling (and mock-ups) with the CCDSs and manage communication to internal and external stakeholders as applicable to ensure timely implementation.
  4. Contact for the assigned products towards Swissmedic and respond within required deadlines to Swiss Authorities.
  5. Represent Regulatory Affairs for the defined product portfolio in internal cross-functional meetings and projects.
  6. Support LOC QA Switzerland for product releases.
  7. Maintain global and local regulatory databases and systems to ensure accurate records of regulatory activities and documentation.
  8. Review promotional and educational materials for the assigned product portfolio.
  9. Contribute to Regulatory Intelligence and assess impact on local business and products.
  10. 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.

Your profile:

  1. University degree in Pharmacy or other scientific studies.
  2. Minimum 2–5 years’ experience in Regulatory Affairs within a pharmaceutical company, CRO, similar organization in Switzerland or Swissmedic.
  3. Advanced knowledge of applicable Swiss laws, regulations, and codices for pharmaceutical industry in Switzerland.
  4. Business fluency in German and English (speaking and writing).
  5. Cross-functional mindset: Strong communicator with the ability to engage both external and internal customers.
  6. 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.
  7. Readiness to adapt to changing situations and drive necessary adaptations.

Desirable Additional Skills:

  1. Additional national language is a plus (French / Italian).

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world. Learn more at takedajobs.com.

Diversity, Equity and Inclusion

At our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

80-100%

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