Senior Remote Regulatory Affairs Specialist — Global Pharma

Placements24; Rustenburg; Hybrid; ZAR 1,279,000 - 1,918,000; Full time

Benefits offered by this job

Home office setup

Healthcare benefits

Annual leave

Professional development

Job summary

Placements24 is seeking a Regulatory Affairs Specialist to join a fully remote, globally distributed team. You will prepare, compile, and submit regulatory dossiers, ensuring compliance across international markets and staying current with evolving regulations.

You will work autonomously yet collaborate with R&D, Quality, and Manufacturing to drive regulatory strategy and lifecycle management for diverse pharmaceutical products.

Qualifications

• Advanced knowledge of global regulatory requirements.
• Experience preparing regulatory dossiers for multiple markets.
• Ability to work independently in a remote cross-functional team.

Responsibilities

• Prepare and submit regulatory applications (NDAs, MAAs, variations) to health authorities worldwide.
• Interpret and apply pharmaceutical regulations, guidelines, and standards.
• Maintain regulatory compliance for products throughout their lifecycle.
• Liaise with R&D, Quality, Manufacturing and external partners on regulatory matters.
• Track regulatory intelligence and assess impact of new regulations on product strategy.
• Manage post-approval changes and updates to product registrations.

Skills

Regulatory affairs

Regulatory submissions

FDA/EMA knowledge

Communication skills

Education

Pharmacy/Chemistry/Biology degree

Tools

Regulatory databases

Job description

Placements24 is seeking a Regulatory Affairs Specialist to join a fully remote, globally distributed team. You will prepare, compile, and submit regulatory dossiers, ensuring compliance across international markets and staying current with evolving regulations.

You will work autonomously yet collaborate with R&D, Quality, and Manufacturing to drive regulatory strategy and lifecycle management for diverse pharmaceutical products.