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Regulatory Affairs Pharmacist

  • Ad Placed : 16 Sep 2019 13:09:12
  • Remuneration : PER MONTH
  • Employment Type : Full Time
  • Employment Level : Professional
  • Industry :
  • Medical
  • Region : Gauteng / Johannesburg
  • Company : Qetello

Requirements BPharm Degree 3 Years Regulatory Affairs experience. Exposure to Production will be an advantage Remuneration: Market related (based on experience and qualification) Delivery of New Product Submission Plan Submission of new dossiers as per the annual product submission plan to SAHPRA and MRA’s of other designated territories according to the latest guidelines. Ensure the screening application is submitted within the stipulated time frame from the date of receipt of the dossier from the company. Delivery of Future Registrations Continuous liaison with SAHPRA to ensure new product registrations are received on time to satisfy the requirements of the business. Compilation of responses to all allocated SAHPRA pre-registration recommendations within a stipulated time frame. Physical and electronic superseding of the dossier with pre-registration responses. Life Cycle Management To ensure that necessary variations are made to the Registration Dossier according to latest requirement of the MRA. To ensure timely submission and approval of variations. To ensure that the MRA is informed of changes to the registration dossier. Printed Packaging Material (PPM) Development and Control Review of all PPM for launch products. Assist in the maintenance of all PPM’s and implementation of any regulatory changes to PPM’s as required.

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