Remote Regulatory Affairs Lead – Global Submissions

Placements24; Durban; Hybrid; ZAR 1,000,000 - 1,400,000; Full time

Benefits offered by this job

Health insurance

Performance bonuses

Remote-first environment

Paid time off

Retirement savings plan

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist for a fully remote role, supporting global regulatory submissions from South Africa. The ideal candidate will lead preparation of dossiers (NDAs, MAAs) and manage lifecycle activities across FDA, EMA, SAHPRA and other agencies.

Strong ICH knowledge and experience with eCTD are essential. The role requires 6+ years in regulatory affairs, a life sciences degree, and a track record of working independently in a remote setting.

Qualifications

• Extensive regulatory affairs experience with drug submissions (NDA/MAA/IND) and lifecycle management.
• Solid knowledge of ICH guidelines and global regulatory requirements.
• Experience with electronic submission formats and gateways (eCTD) is essential.

Responsibilities

• Prepare and submit high-quality regulatory dossiers to major health authorities.
• Develop regulatory strategies for product registration and lifecycle management.
• Monitor regulatory changes and advise on potential impact to dossiers and labeling.
• Collaborate with R&D, Manufacturing and Marketing to ensure compliance.
• Provide regulatory guidance and training to internal teams.

Skills

Regulatory strategy

Dossier submission

Global regulatory knowledge

Independent work

Education

Bachelor's or Master's in Pharmacy/ Chemistry/ Biology

PhD is a plus

Tools

eCTD

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist for a fully remote role, supporting global regulatory submissions from South Africa. The ideal candidate will lead preparation of dossiers (NDAs, MAAs) and manage lifecycle activities across FDA, EMA, SAHPRA and other agencies.

Strong ICH knowledge and experience with eCTD are essential. The role requires 6+ years in regulatory affairs, a life sciences degree, and a track record of working independently in a remote setting.