Remote Regulatory Affairs Specialist: Global Submissions

Placements24; Klerksdorp; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Remote work

Health insurance

Home office stipend

Professional development

International regulatory conferences

Flexible hours

Retirement savings plan

Job summary

Placements24 is seeking a Remote Regulatory Affairs Specialist to prepare and submit regulatory dossiers for global drug development. You will work from home, coordinating with authorities such as SAHPRA, FDA and EMA to ensure timely approvals and lifecycle management.

The role requires a strong background in regulatory affairs, with 5+ years in dossier preparation and knowledge of ICH guidelines and eCTD formats. Remote work offers flexibility, with a collaborative, global team environment.

Qualifications

• 5+ years in pharmaceutical regulatory affairs with dossier preparation.
• Knowledge of global guidelines (ICH, FDA, EMA, SAHPRA) and eCTD formats.
• Ability to work independently in a remote, deadline-driven environment.

Responsibilities

• Prepare, compile, and submit regulatory dossiers (CTD/eCTD) for drug registrations and lifecycle management.
• Liaise with health authorities (SAHPRA, FDA, EMA) to address queries and manage submissions.
• Ensure all submissions are accurate, complete, and compliant with guidelines and policies.
• Monitor regulatory landscape changes and assess impact on submissions.
• Collaborate with R&D, Quality, Manufacturing, and Legal to gather filing information.
• Provide regulatory guidance and strategic advice to project teams during development.
• Review promotional materials and labeling for regulatory compliance.
• Maintain regulatory databases and track status of submissions and approvals.
• Contribute to SOPs and work instructions within the department.

Skills

Regulatory expertise

Attention to detail

Project management

Documentation & writing

Communication skills

Education

Bachelor's degree in Pharmacy, Chemistry, Biology or related life science

MSc or PhD in regulatory science or related field

Tools

RIM systems

Job description

Placements24 is seeking a Remote Regulatory Affairs Specialist to prepare and submit regulatory dossiers for global drug development. You will work from home, coordinating with authorities such as SAHPRA, FDA and EMA to ensure timely approvals and lifecycle management.

The role requires a strong background in regulatory affairs, with 5+ years in dossier preparation and knowledge of ICH guidelines and eCTD formats. Remote work offers flexibility, with a collaborative, global team environment.