Remote Senior Regulatory Affairs Leader-Global Submissions

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

Benefits offered by this job

Salary commensurate with experience

Health insurance

Retirement savings plan

Performance-based bonuses

Flexible remote working

Job summary

Placements24 is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies for global pharmaceutical products in a remote role. You will guide product development teams through regulatory requirements for timely approvals with SAHPRA, FDA, and EMA interactions.

You will mentor the regulatory affairs team, manage lifecycle activities, ensure compliant labeling and promotional materials, and contribute to internal SOPs and process improvements.

Qualifications

• Bachelor's or Master's in Pharmacy, Chemistry, Biology, or related field (advantage: higher degree).
• 8+ years in pharmaceutical regulatory affairs with successful submissions.
• Knowledge of SAHPRA, US FDA, and EMA regulatory requirements.

Responsibilities

• Develop and execute regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (CTD, MAA, NDA) to health authorities.
• Liaise with regulatory agencies and address queries to facilitate approvals.
• Provide regulatory input into development plans, CTD strategies, and manufacturing processes.
• Mentor junior staff and manage post‑approval variations and renewals.

Skills

Regulatory strategy

Dossier submission

Regulatory intelligence

Stakeholder management

Education

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

Tools

Regulatory information management systems

Job description

Placements24 is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies for global pharmaceutical products in a remote role. You will guide product development teams through regulatory requirements for timely approvals with SAHPRA, FDA, and EMA interactions.

You will mentor the regulatory affairs team, manage lifecycle activities, ensure compliant labeling and promotional materials, and contribute to internal SOPs and process improvements.