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Regulatory Affairs Manager, Denmark

About the Opportunity

Join Sanofi Denmark as a Regulatory Affairs Manager responsible for obtaining and maintaining marketing authorizations for assigned products and managing the interactions with the local Health authority.

This is an office-based role located in Copenhagen, Denmark.

About Sanofi

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence. We want to focus on those areas where we know we are making a difference. 

About growing with us

In this role you will….

  • Be responsible for obtaining and maintaining marketing authorizations for all assigned products

  • Manage interactions with the Health Authority for all assigned products

  • Create and maintain the local Product Information

  • Maintain the creation of packaging materials in accordance with local requirements

  • Proactively collaborate with the local Brand Teams for all assigned products

  • Successfully integrate regulatory strategies into local product activities

  • Proactively participate in local launch activities

  • Review the promotional materials for all assigned products

  • About you

    Qualifications/ Education & work experience

  • University degree in life science e.g. pharmacy or equivalent
  • 5+ years of pharmaceutical industry experience or equivalent
  • Regulatory Affairs experience and knowledge of product lifecycle activities
  • Solid knowledge of local and EU regulatory guidelines and legislations
  • Ability to raise regulatory concerns and opportunities in a cross-functional setting
  • Excellent communication and presentation skills – both written and verbal
  • Strong collaboration skills with an ability to effectively partner with strategic stakeholders
  • Willingness to proactively seek information about project/product activities
  • Ability to lead and influence decisions
  • Ability to work independently as well as part of a cross-functional team
  • Oral and written fluency in English and Danish
  • Inspire your Journey: what Sanofi can offer you:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
  • An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
  • An individual and well-structured introduction and training when you onboard.
  • You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
  • As a globally successful and constantly growing company, Sanofi provides international career paths as well.
  • This is our Sanofi. Discover yours.

    If you feel you have the required experience please apply, alternatively contact directly for more details.

    Own your future. Make your move!

    We are proud to have been awarded Global Top Employer 2021!

    At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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    Modtag jobannoncer der minder om dette job i din indbakke.

    Når du tilmelder dig accepterer du samtidig vores privatlivspolitik. Du kan altid trække dit samtykke tilbage.