Remote Regulatory Affairs Leader

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

Benefits offered by this job

Premium health insurance

Retirement contributions

Remote-first with Pretoria office tie

Professional development budget

Job summary

Placements24 is seeking a strategic Regulatory Affairs Manager to lead regulatory operations remotely with strong ties to the Pretoria office. You will develop regulatory strategies, oversee submissions, and liaise with health authorities to ensure compliance and market authorization across territories.

The role requires advanced degrees or equivalent experience, 8+ years in pharma, and at least 3 years in a leadership capacity.

Qualifications

• Advanced degree (e.g., Pharmacy, Law, Sciences) or equivalent experience in regulatory affairs.
• 8+ years of progressive experience in the pharmaceutical industry with 3+ years in management.
• Knowledge of global regulatory requirements (SAHPRA, FDA, EMA) and submission processes.
• Experience in managing regulatory submissions and interactions with health authorities.

Responsibilities

• Develop regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD) to health authorities.
• Serve as primary contact with regulatory agencies and respond to inquiries.
• Monitor regulatory changes and assess their impact on products and strategies.
• Provide regulatory guidance to R&D, manufacturing, and commercial teams.

Skills

Leadership

Regulatory strategy

Dossier submission

Stakeholder communication

Education

Pharmacy degree

Law degree

Science degree

Job description

Placements24 is seeking a strategic Regulatory Affairs Manager to lead regulatory operations remotely with strong ties to the Pretoria office. You will develop regulatory strategies, oversee submissions, and liaise with health authorities to ensure compliance and market authorization across territories.

The role requires advanced degrees or equivalent experience, 8+ years in pharma, and at least 3 years in a leadership capacity.