Remote Pharma Regulatory Affairs Specialist - Global Health

Placements24; Rustenburg; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Fully remote work

Health and wellness benefits

Professional development opportunities

Global health impact

Job summary

Placements24 is seeking a dedicated Remote Pharmaceutical Regulatory Affairs Specialist to ensure compliance with global pharma regulations. You will prepare, submit, and maintain regulatory filings from your home office, liaising with authorities and guiding regulatory strategy.

The role requires 5+ years in regulatory affairs, deep knowledge of FDA/EMA/SAHPRA, and strong communication to support market access for innovative products worldwide.

Qualifications

• Bachelor's degree in Pharmacy or Life Sciences; advanced degree preferred.
• Minimum 5 years in pharmaceutical regulatory affairs.
• Experience with FDA, EMA, SAHPRA regulatory submissions.

Responsibilities

• Prepare, review, and submit regulatory filings (IND, NDA, MAA) to authorities worldwide.
• Maintain registrations and ensure ongoing regulatory compliance.
• Interpret requirements and guide project teams on regulatory strategy.
• Communicate with regulatory agencies and address deficiencies.
• Monitor regulatory landscape and assess impact on products.
• Manage post-approval lifecycle activities including variations and renewals.

Skills

Regulatory submissions

Global regulations

Regulatory strategy

Remote work capability

Education

Bachelor's degree in Pharmacy

Job description

Placements24 is seeking a dedicated Remote Pharmaceutical Regulatory Affairs Specialist to ensure compliance with global pharma regulations. You will prepare, submit, and maintain regulatory filings from your home office, liaising with authorities and guiding regulatory strategy.

The role requires 5+ years in regulatory affairs, deep knowledge of FDA/EMA/SAHPRA, and strong communication to support market access for innovative products worldwide.