Regulatory Affairs Manager

vor 1 Woche

Rotkreuz, Zug, Schweiz Amgen Vollzeit

HOW MIGHT YOU DEFY IMAGINATION?:

If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. The Regulatory Affairs (RA) Team in the Swiss Affiliate is looking for a Regulatory Affairs Manager (80%). It's time for a career you can be proud of. Join us.

Regulatory Affairs Manager - 80% (Swiss Affiliate)

LIVE:

What you will do
Let's do this. Let's change the world.

In this business critical role you will provide expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.


  • Plan and manage local regulatory submissions to Swissmedic in compliance with corporate standards and local legal requirements (e.g. HMG, Arzneimittelzulassungsverordnung AMZV)
  • Maintain existing product registrations (variations, renewals, line extensions, manufacturing changes, postapproval commitments), devise and implement local product related regulatory strategies, in compliance with corporate standards and local legal requirements
  • Prepare and submit new Marketing Authorisation Applications in accordance with local legal and internal requirements
  • Act as a contact to Swissmedic in fulfilling local marketing authorisation obligations
  • Maintain and approve local labelling, review promotional material Arzneimittel-Werbeveordnung AWV, Pharma Codex

WIN:

What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients.

What we seek in you as an expert professional are these qualifications and skills:

Basic Qualifications:

  • You posses a Bachelor's degree and 5 years of directly related experience
  • You are fluent in German and English, both written and spoken
  • Regulatory expertise for Switzerland
  • Strong communication and organizational skills
  • Ability to input effectively on multi functional teams
  • Ability to anticipate and prevent potential issues
  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

Preferred Qualifications:

  • Fluency in French
  • Regulatory expertise for EU and biotechnology products
  • Experience in building relationships with regulatory authorities
  • Experience in working within a global corporate environment
  • Experience in defining and implementing policies, procedures and SOPs

THRIVE:

What you can expect of us


As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.


  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

APPLY NOW:

For a career that defies imagination


In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt.

Join us.

Equal Opportunity Statement


Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us


If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics.

Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.


As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win.

Together, we live the Amgen values as we continue advancing science to serve patients.

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