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Senior Manager Regulatory Affairs (m/f) - Spain  

PHARMALEX (company)

Posted on : 06 April 2017

Project Description

  •  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.

Full-time Employee (m/f) for Senior Manager Regulatory Affairs

Your Tasks
  • Planning and conducting authorization procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as lifecycle management procedures (variations, renewals, MAH transfers, etc.) worldwide
  • Communication in the project team, with customers, local partners and representatives in the international context
  •  Supervise and coordinate Life Cycle Management processes and development projects and marketing authorization procedures with regard to the pharmaceutical quality documentation

Your Profile
  • Degree in natural sciences (preferably pharmacy, chemistry or biology)
  • At least 3 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

Good to have
  • Experience in Pharmaceutical Quality with a focus on regulatory aspects of the pharmaceutical quality documentation
  • Practical experience in regulatory e-submissions and in Regulatory Compliance

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
  • If you are interested to take up the challenge at our future-oriented company and would like to grow together with our company, please send us your detailed application  via E-mail.

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