Regulatory manager

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