Remote Regulatory Affairs Specialist — Global Pharma Strategy

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Remote work flexibility

Professional development

Paid time off

Job summary

Placements24 in South Africa seeks a highly experienced Remote Pharmaceutical Regulatory Affairs Specialist to navigate global regulatory landscapes, manage submissions, and ensure compliance for a diverse portfolio across international markets. You will lead regulatory strategy, liaise with authorities, and collaborate with R&D, manufacturing, and marketing in a fully remote setup.

The role requires 7+ years in regulatory affairs, strong knowledge of FDA/EMA/PMDA guidelines, and a proven track

Qualifications

• Bachelor's or Master's in life science, pharmacy, or related field; PhD a plus.
• Minimum 7 years in pharmaceutical regulatory affairs with global scope.
• Proven track record of successful regulatory submissions and approvals.
• Strong knowledge of drug development, GMP/GCP, and manufacturing basics.
• Experience with eCTD and multiple submission formats.
• Analytical, strategic thinker with excellent written and verbal communication.
• Ability to work independently and manage multiple remote projects.

Responsibilities

• Prepare, review, and submit regulatory documentation for filings worldwide.
• Develop global regulatory strategies to support development and commercialization.
• Monitor evolving guidelines; advise on impact to products and operations.
• Liaise with health authorities during submissions and reviews.
• Ensure compliance with local and international regulations and guidelines.
• Conduct regulatory intelligence to identify trends and risks.
• Collaborate with R&D, clinical operations, manufacturing, and marketing.
• Manage post-approval lifecycle activities and compliance reporting.

Skills

Regulatory affairs

Regulatory strategy

Analytical thinking

Communication

Project management

Remote work

Decision making

Education

Bachelor's or Master's in life science/pharmacy

PhD or advanced degree a plus

Tools

eCTD

Regulatory databases

Job description

Placements24 in South Africa seeks a highly experienced Remote Pharmaceutical Regulatory Affairs Specialist to navigate global regulatory landscapes, manage submissions, and ensure compliance for a diverse portfolio across international markets. You will lead regulatory strategy, liaise with authorities, and collaborate with R&D, manufacturing, and marketing in a fully remote setup.

The role requires 7+ years in regulatory affairs, strong knowledge of FDA/EMA/PMDA guidelines, and a proven track