Remote Regulatory Affairs Specialist: Global Dossiers

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

Benefits offered by this job

Competitive salary

Generous paid time off

Home office stipend

Health insurance

Job summary

Placements24 is seeking a Remote Regulatory Affairs Specialist to support a global team from Centurion, Gauteng. You will ensure compliance with national and international pharmaceutical regulations, manage regulatory dossiers, and stay ahead of evolving regulatory landscapes.

The role requires a Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field, at least 4 years in regulatory affairs, and excellent English communication.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences or related field; advanced degree preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting drug registration dossiers.
• In-depth knowledge of regulatory requirements in SA, Europe and USA.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD format) to health authorities (SAHPRA, FDA, EMA).
• Monitor regulatory guidelines and advise on their impact on products and strategies.
• Maintain regulatory documentation with accuracy and compliance.
• Liaise with R&D, Manufacturing, Marketing and external regulatory bodies.

Skills

Regulatory affairs

Dossier submission

Regulatory intelligence

Communication

Education

Bachelor’s degree in Pharmacy, Chemistry, Life Sciences

Job description

Placements24 is seeking a Remote Regulatory Affairs Specialist to support a global team from Centurion, Gauteng. You will ensure compliance with national and international pharmaceutical regulations, manage regulatory dossiers, and stay ahead of evolving regulatory landscapes.

The role requires a Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field, at least 4 years in regulatory affairs, and excellent English communication.