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At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

 

Our global headquarters, STADA Arzneimittel AG, is located in Bad Vilbel near Frankfurt am Main. For our department Biotechnology we are looking for you as


Manager (f/m/d) Regulatory Affairs Biotechnology/Biosimilars, limited till 12/2022   

Bad Vilbel | Deutschland (DE) | Full-time | Fix-term 

 

Your responsibilities:

 

  • Responsibility for international marketing authorisation applications of biosimilars
  • Preparation and submission of new MA applications and maintenance procedures (variations)
  • Creation and review of regulatory documents (in particular CTD modules 1 and 3) and assurance of regulatory compliance
  • Compilation of dossiers (eCTD) with specific software
  • Regulatory support for new product launches in Europe and other countries
  • Cooperation in inter-team and inter-company project groups

 

Your qualification:

 

  • University degree in life sciences (pharmacy, chemistry, biology, biotechnology or related discipline)
  • Experience with European drug regulatory affairs and the centralised procedure (EMA) is preferable
  • Experience with regulatory intelligence software, publishing tools and document management software is a plus
  • Organisational talent, team spirit and communication skills
  • High engagement and willingness to learn
  • Excellent knowledge of English, German is an advantage

 

We are looking for talents with expert knowledge and an entrepreneurial spirit that enjoy working collaboratively in a global team. We are pleased to get to know you better. Please use our online portal to submit your application: jobs.stada.com

Apply now »