20 May '21
Regulatory Pharmacist

Medical, Gauteng JHB - Eastern Suburbs

Market - Related

A Global Pharmaceutical company based in Johannesburg is seeking a Regulatory Pharmacist to join their dynamic team

A Global Pharmaceutical company based in Johannesburg is seeking a Regulatory Pharmacist to join their dynamic team

Duties:

  • Manage and maintain the integrity of the product dossier to ensure compliancy with the relevant health authority/s.
  • Compile dossier/s and post registration amendments and submit to the relevant health authority
  • Compile and maintain the package insert and patient information leaflet and communicate to QA the latest approved documents
  • Develop relationships with the relevant health authority and country agents to ensure compliance.
  • Communicate and capture the latest requirements and guidelines
  • Manage and maintain the integrity of the product dossier to ensure compliancy with the relevant health authority/s. Update the dossier with the relevant quality, safety and efficacy information and communicate such information to the relevant stakeholders when applicable
  • File the hard copy dossier, correspondence and amendment files in the relevant area. Supersede, file, print, scan and bind the dossier, correspondence and amendments to ensure an up to date product dossier in hard copy
  • Scan and save the product dossier, correspondence and amendments in the correct product dossier folder structure. Ensure that the hard copy information is the same as electronic copy
  • Manage the product/s registration certificate/s and ensure that it is available in hard copy and electronically.
  • Built baseline dossiers converting the dossier information to the latest CTD format
  • Manage the product/s relevant technical, quality, safety, risk, recent movements and efficacy information and communicate to the relevant stakeholders.
  • Capture the information in the product information sheet, trackers to ensure accurate information reported.
  • Conduct evaluations (due diligences) against the health authorities requirements and manage the information request and received accordingly, and in a timely manner
  • Compile dossier/s and post registration amendments and submit to the relevant health authority.
  • Follow up and respond in a timely manner to the health authority’s recommendations
  • Ensure that product dossiers and registration certificates communicate the correct final product manufacturers and laboratories. Ensure and facilitate that the latest GMP certificates, manufacturing license and Site Master Files are either in the dossier or available
  • Ensure that the relevant product/s Quality/Technical agreements are in place
  • Ensure that the artwork (pack, PI and PIL) in the market is in line with the dossier; facilitate any discrepancy between the dossier, registration certificate and the commercial artwork with QA.
  • Compile and maintain the package insert and patient information leaflet and communicate to QA the latest approved documents.
  • Ensure that the dossier contain the process validation report where the validations batches were manufactured with the correct formulation, method of manufacturing and in the registered manufacturing site
  • Ensure that the current analytical methods are validated and update the dossier accordingly. Verify if the specifications and COA are in line with each other and communicate to QA any findings related to specifications and procedures
  • Make sure that the dossier contains stability data manufactured with API from the registered API manufacturer, in the registered manufacturing site, packed in the packaging available in the market/s.
  • Ensure that the relevant environmental conditions are clearly communicated to QA to ensure the role out of a stability program to satisfy our target countries.
  • Manage the safety and efficacy requirements related to your product/s to satisfy existing health authorities as well as in the developing territories
  • Ensure that new product samples are kept according to the required environmental conditions
  • Verify marketing material on your product/s and ensure that it is line with the product/s dossier, Martindale, relevant SOP and local legislation in the relevant country
  • Maintain registrations of products in the related countries.
  • Track recent developments of new registrations and/or amendments and ensure that the retention fees are paid. Manage the registration certificates, if applicable.
  • Develop relationships with the relevant health authority and country agents to ensure compliance. Communicate and capture the latest requirements and guidelines
  • Manage products, projects and areas in a responsible manner and in a timely manner.

Requirements:

  • Tertiary qualifications in pharmacy (BPharm)
  • Registration with the Pharmacy Council, South Africa
  • Minimum 3 years Regulatory experience
  • Experience/exposure to pharmacovigilance and clinical work is a recommendation.
  • Good project management skills.
  • Well-developed problem solving and analytical skills.
  • Excellent written and verbal communication skills.
  • Attention to detail.
  • Well-developed interpersonal skills, negotiation skills and customer focus.
  • Ability to work well in a team environment.

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.

Ad Visible Until: 19 June 2021
Ref: CPT000150/CH

Vacancy Type: Permanent