Remote Global Regulatory Affairs Specialist

Placements24; Richards Bay; Hybrid; ZAR 600,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary & incentives

Health insurance

Flexible remote

Paid vacation & holidays

Learning & development

Global regulatory exposure

Job summary

Placements24 is seeking a highly knowledgeable Regulatory Affairs Specialist to join our client’s remote team, focusing on navigating global regulatory landscapes for pharmaceutical products. You will prepare and submit dossiers, liaise with health authorities, and advise on regulatory strategy to support market access.

The ideal candidate has a strong understanding of ICH, FDA, EMA guidelines, excellent communication skills, and at least five years of experience in regulatory affairs.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's degree or equivalent experience preferred.
• Minimum of 5 years in pharmaceutical regulatory affairs.
• Experience in preparing and filing regulatory submissions in key global markets.
• In-depth knowledge of international pharmaceutical regulations and guidelines (ICH, FDA, EMA).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage timelines, and prioritize tasks effectively in a remote environment.

Responsibilities

• Prepare, review, and submit regulatory documentation for NDAs and variations in various international markets.
• Liaise with global health authorities (FDA, EMA, SAHPRA) to facilitate communication and respond to queries.
• Monitor and interpret evolving regulatory guidelines and advise on strategic compliance measures.
• Ensure that product labeling and promotional materials comply with regulatory requirements.
• Conduct regulatory intelligence activities to identify potential risks and opportunities.
• Support regulatory aspects of post-market surveillance and lifecycle management of products.

Skills

Regulatory affairs

Communication

Time management

Remote work

Education

Bachelor's degree in Pharmacy/Life Sciences

Master's degree preferred

Job description

Placements24 is seeking a highly knowledgeable Regulatory Affairs Specialist to join our client’s remote team, focusing on navigating global regulatory landscapes for pharmaceutical products. You will prepare and submit dossiers, liaise with health authorities, and advise on regulatory strategy to support market access.

The ideal candidate has a strong understanding of ICH, FDA, EMA guidelines, excellent communication skills, and at least five years of experience in regulatory affairs.