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Open nowFirst seen 5 days ago

Regulatory Affairs Pharmacist

Ithemba Recruitment- Sourcing Top Talent650 open roles

Where
Johannesburg, GP, South Africa
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Your applicationOpen nowRegulatory Affairs PharmacistIthemba Recruitment- Sourcing Top Talent · Johannesburg, GP, South Africa

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Ithemba Recruitment- Sourcing Top Talent's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

The posting

Key purpose:

To fulfill the position as regulatory affairs pharmacist for the company and any division within the group.

Duties and 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.
  • Training and peer review of documents

Qualifications and experience:

  • Bachelor of Pharmacy Degree
  • Minimum 2 years experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan
  • Attention to detail
  • Pharmacovigilance is an advantage
  • 2 Years experience in regulatory affairs and attention to detail

Skills and competencies:

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