Global Regulatory Affairs Specialist - Remote

Placements24; Rustenburg; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Health and dental insurance

Flexible remote work

PTO and professional development

Impact global health

Job summary

Placements24 is seeking a Regulatory Affairs Specialist to support pharmaceutical operations from a remote setting. You will prepare and submit regulatory documentation to health authorities worldwide, ensuring compliance with FDA, EMA, and ICH guidelines.

Ideal candidates have a minimum of 5 years experience in regulatory affairs and strong written/verbal communication skills. The role offers a fully remote arrangement within South Africa, with competitive compensation and benefits.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field.
• Minimum of 5 years in pharmaceutical regulatory affairs with global submissions.
• Strong knowledge of FDA, EMA, ICH guidelines and dossier filing.

Responsibilities

• Prepare, review, and submit regulatory submissions to health authorities worldwide.
• Maintain compliance with evolving global regulatory requirements.
• Manage post-approval commitments and lifecycle activities.
• Coordinate with R&D, Manufacturing, Clinical teams and external partners.
• Respond to agency queries in a timely and comprehensive manner.
• Support regulatory strategies for new registrations and lifecycle management.

Skills

Regulatory affairs

Global submissions

Regulatory guidelines

Dossier filing

Autonomous work

Education

Bachelor's degree in Pharmacy, Life Sciences, or related field

Job description

Placements24 is seeking a Regulatory Affairs Specialist to support pharmaceutical operations from a remote setting. You will prepare and submit regulatory documentation to health authorities worldwide, ensuring compliance with FDA, EMA, and ICH guidelines.

Ideal candidates have a minimum of 5 years experience in regulatory affairs and strong written/verbal communication skills. The role offers a fully remote arrangement within South Africa, with competitive compensation and benefits.