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Specialist Regulatory Affairs (m/f) Sofia Bulgaria,  

PHARMALEX (company)

Posted on : 13 June 2017

Project Description

Be a part of our growing company!
  • Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day life? 
  • Then make our company your career choice! our company is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting.
  •  We are specialized in effectively designing all aspects of drug and medicinal product registrations  ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees.
  • We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment. 
  • So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. 

 Your responsibilities
  • Planning and conducting authorization procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as life-cycle management procedures (variations, renewals, MAH transfers, etc.) worldwide
  • Communication in the project team, with customers, local partners and representatives in the international context
  • Review of approval documents and text management (labeling management)

 Your profile
  • Degree in natural sciences (preferably medicine, pharmacy, chemistry or biology)
  • At least 1 year of professional experience in drug licensing with a focus on EU or with admission procedures in non-EU countries and experience with Launch Management, Labelling Management, Clinical Trial Applications and admission procedures in non-EU countries.
  • Solid knowledge of current drug and regulatory requirements (EU)
  • First experience in a multi-task consulting environment
  • IT affinity to databases and the handling of project management software
  • Team-oriented, communicative, conscientious, accurate and responsible
  • Flexibility to travel
  • Secure MS Excel and Word knowledge as well as confident English skills

We offer you
Exciting and varied challenges in a friendly team, contact and interaction with nearly all branches of the company, as well as many opportunities for personal development and job training.



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