Global Remote Pharma Regulatory Affairs Specialist

Placements24

Mossel Bay

Hybrid

ZAR 600,000 - 1,000,000

Full time

5 days ago

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Benefits offered by this job

Competitive salary and bonuses

Health insurance

Flexible remote work hours

Professional development budget

Job summary

Placements24 is seeking a highly organized Remote Pharmaceutical Regulatory Affairs Specialist to join our global team. You will prepare, review, and submit regulatory dossiers to global authorities, and provide strategic regulatory guidance to product development.

This fully remote role requires in-depth knowledge of FDA, EMA, SAHPRA and strong communication for cross-border collaboration. The ideal candidate has a Bachelor's in Pharmacy, Chemistry or Biology (Master's preferred) and at least 4

Qualifications

Bachelor's degree in a scientific field (Pharmacy, Chemistry, Biology)
4+ years of regulatory affairs experience
Strong knowledge of global regulatory requirements (FDA, EMA, SAHPRA)
Experience preparing and submitting regulatory dossiers
Excellent written and verbal communication, high accuracy
Ability to work independently and manage multiple projects remotely

Responsibilities

Prepare and compile regulatory submission dossiers (NDAs, MAAs, variations) for global health authorities
Review and approve labeling and promotional materials for compliance
Liaise with regulatory agencies and manage submissions through approval
Develop regulatory strategies for product registration and lifecycle management
Monitor regulatory intelligence and advise on changes in requirements
Maintain regulatory databases and accurate record-keeping