Cimas is looking for a Regulatory Affairs Specialist

Regulatory Affairs Specialist

Application deadline date has been passed for this Job.
This job has been Expired

Regulatory Affairs Specialist

  • Post Date:July 24, 2023
  • Views 1098
0 Applications
  • Career Level Specialist
    Qualification Degree
    Experience 1-3 Years
  • Industry Health Care
Job Description

The Group wishes to invite applications from suitably qualified & experienced individuals to fill in the Regulatory Affairs Specialist role that has arisen in our organisation.

The Role

  • Participates in the implementation and development of the Regulatory Strategy.
  • Develops and updates Standard Operating Procedures for registration of medicine with MCAZ in line with local and international legislature.
  • Develops and updates the budget for product registrations consolidating inputs, requirements, and allied products from the relevant units.
  • Assembles a regulatory file/dossier by coordinating the acquisition for all applicable data, assessed data and drafts.
  • Verifies if collected data complies with current local and international legislature format.
  • Analyses and verifies file contents.
  • Conducts accurate assessments to anticipate questions and critical issues from the regulator.
  • Submits the regulatory file to MCAZ.
  • Updates clinical and pre-clinical data.
  • Responds to questions from regulatory authorities.
  • Conducts Regulatory monitoring of approved products.
  • Monitors commitments/obligations in line with regulatory requirements.
  • Assists and supports in house teams with compliance.
  • Prepares Weekly and monthly reports.

The Person

 

  • Degree in Science (Pharmacy, Pharmacology, Biochemistry) or related discipline.
  • Certificate in Dossier assessments.
  • At least 2 years experience.
  • Master`s Degree in related discipline is an added advantage.
  • Excellent verbal and written communication skills and an ability to prepare accurate reports.
  • Ability to plan and organise in line with job requirements.
  • Ability to analyse and solve work related problems while achieving the right outcome simultaneously.
  • Ability to interact, negotiate (where applicable) and achieve targets.

If you are interested and you meet the stipulated requirements, please submit your letter of motivation and CV to this email [email protected] no later than Monday the 24th of July 2023.

Clearly highlight the position applied for in the email subject.