Global Regulatory Affairs Specialist — Remote

Placements24; Pretoria; Híbrido; ZAR 700.000 - 1.100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Health benefits

Remote work options

Professional development

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

Regulatory affairs

Pharmaceutical submissions

Regulatory analysis

Communication skills

Educación

Bachelor's degree in Pharmacy/ Life Sciences/ related

Master's degree preferred

Herramientas

Regulatory information management systems

Electronic submission formats

Descripción del empleo

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.