Senior Regulatory Affairs Lead - Hybrid, Global Dossier

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

Vantaggi offerti da questo lavoro

Private medical insurance

Retirement fund

Annual bonuses

Hybrid work arrangement

Descrizione del lavoro

Placements24 is seeking an experienced Senior Regulatory Affairs Specialist in Benoni, Gauteng, to lead dossier submissions for international markets. The role requires deep knowledge of CTD/eCTD, SAHPRA, FDA and EMA guidelines, and collaboration with R&D, QA, manufacturing and marketing teams.

You will manage submission plans, ensure labeling and product information compliance, and monitor regulatory changes to keep the portfolio on track for timely registrations and lifecycle management.

Competenze

• Minimum 5 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience with dossier preparation and submission (CTD/eCTD).
• Experience interacting with regulators (SAHPRA, FDA, EMA).
• Knowledge of CMC requirements and labeling/packaging compliance.

Mansioni

• Prepare, review and manage regulatory dossiers for new drugs, variations and renewals.
• Apply ICH, FDA, EMA and SAHPRA guidelines to submission strategies.
• Liaise with national and regional health authorities to address queries.
• Develop submission plans and timelines aligned with development strategy.

Conoscenze

Attention to detail

Regulatory intelligence

Strong communication

Project management

Formazione

Bachelor's degree in Pharmacy, Chemistry, Biology

Master's or PhD (advantage)

Strumenti

Regulatory information management systems

Descrizione del lavoro

Placements24 is seeking an experienced Senior Regulatory Affairs Specialist in Benoni, Gauteng, to lead dossier submissions for international markets. The role requires deep knowledge of CTD/eCTD, SAHPRA, FDA and EMA guidelines, and collaboration with R&D, QA, manufacturing and marketing teams.

You will manage submission plans, ensure labeling and product information compliance, and monitor regulatory changes to keep the portfolio on track for timely registrations and lifecycle management.