Remote Regulatory Affairs Specialist, Global Pharma

Placements24; Bloemfontein; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Remote work flexibility

Competitive compensation

Career growth opportunities

Home office stipend

Job summary

Placements24 is seeking a seasoned Remote Regulatory Affairs Specialist to join a global pharmaceutical team. This fully remote role focuses on managing regulatory submissions across international markets from a home office, with occasional meetings near Welkom if needed.

The ideal candidate has 4–6 years of regulatory affairs experience, a life sciences degree, and a proven track record in CTD/MAA submissions, ICH, FDA, and EMA guidelines.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related life science.
• 4–6 years of pharmaceutical regulatory affairs experience.
• Proven track record of regulatory submissions and approvals in major markets.
• Strong knowledge of ICH, FDA, and EMA guidelines.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD/MAA/ANDA) to global authorities.
• Interpret international regulations to ensure product compliance.
• Develop regulatory strategies for registration and lifecycle management.
• Collaborate with R&D, manufacturing, quality to gather submission data.
• Monitor evolving regulatory landscapes and advise on impacts.

Skills

Regulatory affairs

CTD submissions

Global submissions

Project management

Education

Pharmacy degree

Regulatory affairs certification

Tools

ICH Guidelines

FDA/EMA knowledge

Job description

Placements24 is seeking a seasoned Remote Regulatory Affairs Specialist to join a global pharmaceutical team. This fully remote role focuses on managing regulatory submissions across international markets from a home office, with occasional meetings near Welkom if needed.

The ideal candidate has 4–6 years of regulatory affairs experience, a life sciences degree, and a proven track record in CTD/MAA submissions, ICH, FDA, and EMA guidelines.