Global Regulatory Affairs Specialist — Remote

Placements24

Pretoria

Hybrid

ZAR 700,000 - 1,100,000

Full time

5 days ago
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Benefits offered by this job

Competitive salary
Health benefits
Remote work options
Professional development

Job summary

Placements24 is seeking a Regulatory Affairs Specialist to support registration and compliance for pharmaceutical products from Pretoria. You will prepare and submit dossiers, liaise with SAHPRA and other authorities, and monitor evolving regulations to ensure market access.

The role requires 4+ years in regulatory affairs, a pharmacy or life sciences background, and strong analytical and communication skills. Flexible working options are available to support work-life balance.

Qualifications

  • Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
  • Master’s degree preferred.
  • 4+ years of experience in pharmaceutical regulatory affairs.

Responsibilities

  • Prepare, review, and submit regulatory submissions to health authorities (CTD, NDA, ANDA).
  • Interpret and advise on regulatory requirements for pharmaceutical products.
  • Maintain regulatory documentation and ensure compliance with regulations.
  • Act as liaison with regulatory agencies and respond to queries.
  • Track regulatory changes and assess impact on product portfolio.
  • Collaborate with R&D, manufacturing, and commercial teams to align regulatory strategy.

Skills

Regulatory affairs
Pharmaceutical submissions
Regulatory analysis
Communication skills

Education

Bachelor's degree in Pharmacy/ Life Sciences/ related
Master's degree preferred

Tools

Regulatory information management systems
Electronic submission formats

Job description

Placements24 is seeking a Regulatory Affairs Specialist to support registration and compliance for pharmaceutical products from Pretoria. You will prepare and submit dossiers, liaise with SAHPRA and other authorities, and monitor evolving regulations to ensure market access.

The role requires 4+ years in regulatory affairs, a pharmacy or life sciences background, and strong analytical and communication skills. Flexible working options are available to support work-life balance.

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