Senior Regulatory Affairs Lead – Global Pharma

Placements24; Vereeniging; Ibrido; ZAR 900.000 - 1.300.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Retirement savings plan

Paid time off

Relocation assistance

Descrizione del lavoro

Placements24 is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join its strategic team in Vereeniging, Gauteng. The role focuses on ensuring products meet global regulatory requirements and developing submission strategies for SAHPRA, FDA, and EMA.

You will lead regulatory submissions (CTD/ANDA/NDA), liaise with authorities, and guide cross-functional teams through the development and post-approval lifecycle, with opportunities for professional growth and

Competenze

• Bachelor's degree in Pharmacy or life sciences; advanced degree preferred.
• 5–7 years in pharma regulatory affairs.
• Knowledge of ICH, FDA, EMA, SAHPRA guidelines.
• Experience with regulatory dossiers for various dosage forms.

Mansioni

• Develop global regulatory strategies for new products and lifecycle management.
• Prepare and submit CTD/ANDA/NDA dossiers to authorities.
• Liaise with regulators and manage submission communications.
• Ensure labeling and promotional materials comply with regs.
• Provide regulatory guidance to R&D, manufacturing, QA, and marketing.
• Support post-approval variations and annual reports.

Conoscenze

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory intelligence

Project management

Communication

Formazione

Bachelor's degree in Pharmacy/life science

Master's or Ph.D. preferred

Strumenti

Gateway

eCTD

Descrizione del lavoro

Placements24 is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join its strategic team in Vereeniging, Gauteng. The role focuses on ensuring products meet global regulatory requirements and developing submission strategies for SAHPRA, FDA, and EMA.

You will lead regulatory submissions (CTD/ANDA/NDA), liaise with authorities, and guide cross-functional teams through the development and post-approval lifecycle, with opportunities for professional growth and