• Tirane, ofroj vend pune Regulatory

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REQUIREMENTS FOR CANDIDATES

Position: Regulatory Affairs

• University degree (Faculty of Pharmacy or Medicine)
• Experience in the professional position of the associate.
• A high level of organizational, creativity and responsibility for fiduciary obligations.
• Knowledge of English language (written and spoken).
• Use of MS Office packet.



JOB DESCRIPTION:

• Preparation and submission to the National Agency of Medicine and Medical Devices the documents necessary for obtaining marketing authorizations for medicinal products and variation for existing products
• Observation of the established deadlines to remedy deficiencies and/or inconsistencies in the documentation submitted for registration of the respective medicinal product
• Follow up correspondences with Drug Agency

  • Preparation and submission of documents for the documents necessary for registration of prices and the inclusion of medicinal products, for which a marketing authorization has been granted, in the Positive Drug List in accordance with legal requirements
  • Formation of marginal or maximum price
  • Creates, maintains and stores, the dossiers of each medicinal product of the company either electronically and/or in hard copy

EMPLOYEE’S BENEFITS

• Work in a positive, dynamic and stimulating environment.
• Continuous training and specialization.
• Good terms and conditions


Please send your CV with an accompanying letter until date 15.06.2021 to the link below:
https://zentiva.wd3.myworkdayjobs.c...vogen/RA---Pharmacovigilance-Manager_R2462271
Only shortlisted candidates will be contacted.
 
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