Remote Senior Regulatory Affairs Leader | Submissions

Placements24; Cape Town; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Bonus potential

Remote healthcare

Home office stipend

Flexible hours

Impact on strategy

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist for a fully remote role to guide drug development through global regulatory landscapes, develop strategies, prepare submissions, and interact with health authorities worldwide.

The ideal candidate has a Master’s or PhD in a scientific field, 7+ years in regulatory affairs, proven success across major markets, and excellent communication, capable of leading projects autonomously from a home office.

Qualifications

• Masters or PhD in a scientific field.
• 7+ years of regulatory affairs experience.
• Proven track record of successful regulatory submissions and approvals.
• Expert knowledge of international guidelines (ICH, SAHPRA, FDA, EMA).
• Excellent written and verbal communication skills.
• Ability to work autonomously and manage multiple projects remotely.

Responsibilities

• Develop and implement global regulatory strategies for drug development.
• Prepare, review, and submit regulatory dossiers to health authorities worldwide.
• Liaise with regulatory agencies (SAHPRA, FDA, EMA) to address inquiries and facilitate approvals.
• Provide regulatory guidance to R&D, clinical, and commercial teams.
• Monitor evolving guidelines and advise on compliance.
• Conduct regulatory due diligence for collaborations and acquisitions.

Skills

Regulatory affairs

Communication

Autonomous work

Education

Master's or PhD in Pharmacy, Chemistry, Biology or related field

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist for a fully remote role to guide drug development through global regulatory landscapes, develop strategies, prepare submissions, and interact with health authorities worldwide.

The ideal candidate has a Master’s or PhD in a scientific field, 7+ years in regulatory affairs, proven success across major markets, and excellent communication, capable of leading projects autonomously from a home office.