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Confidential Company Hiring for Regulatory Affairs Specialist at Al Kuwait Full Time
EASY APPLY
Job Description
Regulatory and PV Specialist
As RA you will be responsible for:
• New registrations, Variations and Renewal files preparation, coordination with agents for files submission and approvals.
• Obtain and maintain marketing authorizations to all products.
• Maintain packaging material and labelling up-to-date according to HQ / local authorities’ requests.
• Submission of safety data.
• Approval of promotional materials.
As PV you will be responsible for:
You will be responsible for the Pharmacovigilance (PV) system, including compliance with local PV requirements in Kuwait, you will prepare and submit the PV files for all products registration to local authorities, monitor and follow up with local authorities to ensure timely fulfilment of PV requirements. In addition to that you will be the contact point with regulatory authorities as a QPPV and for any inspection purposes.
Last but not least you will be responsible for the reconciliation and quality check of adverse events with all stakeholders as applicable.
Skills
A bachelor degree in pharmaceutical sciences, Solid interpersonal skills and cross functional collaboration. Ability to influence and collaborate with internal and external key stakeholders.Master English both orally and verbally.Minimum of five years regulatory and pharmacovigilance experience in the pharmaceutical field, experience in local RA & PV requirements in Kuwait.
Job Details
Job Location
Al Kuwait, Kuwait
Company Industry
Medical & Healthcare Equipment
Company Type
Employer (Private Sector)
Job Role
Medical, Healthcare, and Nursing
Employment Type
Full Time Employee
Monthly Salary Range
Unspecified
Number of Vacancies
1
Preferred Candidate
Career Level
Mid Career
Years of Experience
Min: 5
Residence Location
Kuwait
Degree
Bachelor’s degree / higher diploma