Pošalji prijatelju

Global Regulatory Affairs Specialist - API (m/f)


Rok prijave:

  • Xellia d.o.o.

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.

With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.

Together you can help us lead the fight against infections.

Further information about Xellia can be found at:
Connect with us on LinkedIn

For our Zagreb team we are looking for

Global Regulatory Affairs Specialist - API (m/f)

Regulatory Affairs

We are looking for a new colleague who would like to join a multi-cultural and professional team of regulatory affairs API specialist. This is a 2 year fixed-term position as a cover for maternity leave.

About Global Regulatory Affairs API team

In the API team we are currently a team of 14 dedicated employees working from Xellia´s sites in Denmark, Hungary, Croatia, China and Japan. We are responsible for all regulatory activities related to Xellias APIs globally. The Global RA API team is part of International Regulatory Affairs – a team of 26.

The job

You will be part of a skilled and enthusiastic team in which your main responsibility will be handling of global regulatory affairs life cycle activities related to the APIs manufactured by Xellia – this includes update of our Drug Master Files (DMF), communication with regulatory authorities and customers referring to the concerned DMFs, participating in internal projects with other RA API colleagues, change control assessment.

On the professional level, you:

  • have a relevant scientific degree within life sciences
  • preferably have experience from a previous job working with Regulatory Affairs – API
  • have good insight into GMP and Quality related activities.
  • good IT skills
  • excellent oral and written English skills

On the personal level, you:

  • are comfortable with delivering good results under time pressure
  • enjoy collaborating with people in a global setup, also when they are different from you
  • have an eye for details, robust and self-motivated

We offer:

In this role you will be given the freedom to handle a wide variety of life cycle management tasks in interaction with a large part of the global organization. In more general terms, Xellia offers an exciting opportunity to contribute and grow. We are large enough to drive change, yet small enough to depend on each single individual in our organization. We have a flat structure, a friendly culture, and a strong will to win and work under a flex-hour setup


To apply for this position, please send your English CV and application letter only via the application link no later than 13.10.2022.

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