Regulatory Affairs & Quality Assurance Specialist

UAE, United Arab Emirates

Job Description

Kinetic has partnered with a leading multinational Pharmaceutical company who are hiring a Regulatory Affairs & Quality Assurance Specialist to be based in the UAE. Candidate must have a valid MOHAP license. Please note that you must meet all the criteria set out below for your application to be considered. Suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion. The main responsibilities will include but not limited to:
  • Define and execute regulatory plans and manage timelines to achieve the stated goals.
  • Liaise closely with Health Authorities, assigned distributors, and agents ensuring the optimum relationship between the regulatory authorities, distributors, and company.
  • Maintenance of assigned, authorized products through timely submission of variations, and renewal applications.
  • Implement GMP and GDP in the company activities.
  • Responsible for approvals & maintenance of regulatory licenses.
  • Ensure marketing materials and product information are according to regulations and dossier.
  • Coordinate and facilitate quality risk management.
  • Updated on relevant local regulations and guidelines.
  • Responsible for verification, certification, and releasing batches as per regulations.
To be successful you will need to meet the following:
  • Degree in Pharmacy.
  • Candidate must have a valid MOHAP license.
  • At least 2 years experience within the Pharmaceuticals Industry.
  • Must have a minimum of 2 years of RRAA experience.
  • Good Knowledge of QA and RA requirements, GCC requirements and compliance regulations, and industry practices.
  • In-depth knowledge of CTD structure and Module 1.
  • Excellent verbal and written English & Arabic language fluency.
  • Motivated, proactive, dynamic, methodical, organised, and decisive.
  • Applicants should be available for face-to-face interviews in the location mentioned above.

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Job Detail

  • Job Id
    JD1533149
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    UAE, United Arab Emirates
  • Education
    Not mentioned