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21.01.2021

Regulatory manager

Маклеодс Фармасьютикалс Лимитед, ООО
Фармацевтика
  • Регион:Киев
Английский (выше среднего)

Macleods Pharmaceuticals Limited invites talented, ambitious and motivated people who are attracted to work professional and career growth for the position of Regulatory manager in Kiev.

REQUIREMENTS:

· Medicine or Pharmacological degree;

· Experience in Regulatory Affairs (minimum 2+ years);

· Intermediate level of English;

· Excellent organizing skills, good oral communication and writing skills, reading comprehension skills, attention to details, critical and analytical thinking;

· Collaborative, tactical, diplomatic, hardworking.

MAIN RESPONSIBILITIES:

Regulatory Affairs

· Handle regulatory submissions (new registration, variation) - compile dossiers in accordance with company and local legislation requirements,

· Planning of regulatory procedures in co-operation with other departments.

· Developing Normative documents, Patient Information Leaflets

· Communication with Regulatory Authorities, outside organizations, and contractors regarding registration of medicine products;

· Cooperation with QPPV from HO