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Senior Manager Regulatory Affairs (m/f) - 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? 
  • 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 (labelling management)
  • Training and supervising of new and/or junior colleagues

 Your profile
  • Degree in natural sciences (preferably medicine, pharmacy, chemistry or biology)
  • At least 5 years 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.
  • Sound knowledge of current drug and regulatory requirements (EU)
  • Experience in project management, 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.