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Regulatory Global CMC associate

Place of work: Belgrade

 

Requirements:

 

  • Education of chemical, medical, pharmaceutical, technological proffesion
  • Active knowledge of English language (written and spoken) - C1 level
  • Advanced level of knowledge of MS Office package
  • Minimum 1 year experience on similar roles

 

Your duties would include:

 

  • Responsibilty for drafting the regulatory documents of the chemical-pharmaceutical quality part of the drug (Modules 2.3. and 3)
  • Product maintenance activities (e.g. renewal and variation) and preparation od IMPDs (dossiers for drugs in the clinical trial phase)
  • Activities related to evaluation / assessment of registration dossiers on a global level
  • Defining activities that need to be carried out as a part of the preparation of responses to the Agency's requests during the procedure of new registrations an/or renewals and variations in Module 3
  • Responsibility for independent planning and implementing the project task and making own decisions related to the project

 

We offer:

 

  • Diverse, challenging and responsible tasks
  • Possibility of promotion and achieving a career progression
  • Work in global environment
  • Competitive salary package

 

 

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