Registration Specialist
Abbott
Russia
8 дней назад

Main responsibilities : Main responsibilities

Main responsibilities

  • Responsibility for developing a comprehensive registration strategy in close cooperation with the personnel dealing with sales, operations, vaccines and marketing, taking into consideration Company's interests and normative requirements.
  • Responsibility for insuring earliest possible registration of all new or in-line products, claims, formulations and / or strengths, along with price registration / re-
  • registration, shelf-life changes according to adopted registration strategies (and company's high ethical standards policy).

  • Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations.
  • Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples, commercial packs and other items are provided to relevant agencies as needed.
  • Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new normatine documents related to registration of medicines.
  • Cultivating best possible relations with local regulatory bodies and opinion leaders and enhancing the Company's image in the medical community in general.
  • Handling all issues related to changes in the Company's products status and performing regulatory related surveys in the country.
  • Preparing and reviewing package labels and inserts for Company's respective new and in-line products registered in the country.Requirements :
  • Requirements :

  • Higher education
  • At least 2 years of experience in Regulatory Affairs (medical equipment, pharmaceuticals, chemical products)
  • Strong willing to develop in IVD regulatory affairs field;
  • English written, spoken
  • Excelent knowledge of MS Office (Word, Excel)
  • Personality : team player, well organized, attentive to details, enthusiastic, quick learner
  • Ability to work with big amount of information
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