Job title: RA pharmacist
Job type: Permanent
Emp type: Full-time
Industry: Pharmaceutical Industry
Skills: Regulatory affairs pharmacist
Location: Johannesburg, Gauteng
Job published: 11/03/2020
Job ID: 32365
Contact name: Linda Pakshong
Contact email: linda@medicalplaces.com

Job Description

Company Compliance:

  • To ensure approval and compliance of printed packaging material and promotional marketing material.
  • Liaising with marketing department to facilitate timeous launch of products.
  • Approval of master batch documentation prior to product production.
  • Responsible for SOP implementation/review, update and compliance.

Product Registration:

  • Liaise with business development for regulatory requirements prior to dossier acquisition.
  • Responsible for anticipating, receiving and submission of new product registrations for a particular financial year. 
  • Responsible for submission of generic dossiers, NCE’s as well as complimentary medicines.
  • Ensure on-going regulatory compliance of the existing product portfolio.
  • Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products.
  • Ensuring that the company is aware of significant local and international regulatory issues which can impact the business.

Documentation management:

  • Managing and maintaining regulatory documentation filing system.
  • Ensuring regulatory compliance and quality related records are available and retained.

SAHPRA Submissions:

  • Responsible for new product applications.
  • Compilation and submission of Post –Registration amendments to ensure dossier compliance.
  • Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure product registration.
  • Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation.

Pharmacovigilance:

  • Responsible for Pharmacovigilance monitoring within the group.