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Johannesburg: Regulatory Affairs Pharmacist posted by OttoBauthentic

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Job Description

MAIN PURPOSE OF JOB

  • Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries

RESPONSIBILITIES

  • 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
  • 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.
  • Managing and maintaining regulatory documentation filing system.
  • Ensuring regulatory compliance and quality related records are available and retained.
  • 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
  • Liaise with business development for regulatory requirements prior to dossier acquisition.

QUALIFICATIONS & EXPERIENCE

  • B. Pharm Degree
  • Minimum 2 years experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan

SKILLS/PHYSICAL COMPETENCIES

  • Docubridge
  • Sage
  • Smartsheet
  • Sweet process
  • Microsoft: Excel, Word, PowerPoint, Outlook

BEHAVIOURAL QUALITIES

  • Takes ownership.
  • Integrity, bound to principles, confidentiality, and ethics.
  • Strong leadership skills.
  • Good communication skills.
  • Good organisational skills.
  • Good planning skills.
  • Good follow-up skills
  • Attention to detail
  • Assertive.
  • Conscientious.
  • Patient.
  • Co-operative.
  • Deadline Driven
View Job  South Africa: Pastry Chef. posted by HotelJobs



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