Job title: Regulatory Affairs Pharmacist
Job type: Permanent
Emp type: Full-time
Industry: Pharmaceutical Industry
Location: Johannesburg, Gauteng
Job published: 19/05/2020
Job ID: 32371
Contact name: Linda Pakshong
Contact email: linda@medicalplaces.com

Job Description

A well established Pharmaceutical Company is seeking an Experienced Regulatory Affairs Pharmacist.  The ideal Candidate must meet the following criteria:

 

Experience gained in the following:

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

 

Other:

  • Providing status reports to the regulatory department head on the status of projects currently worked on
  • System implementation
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