Remote Pharmaceutical Regulatory Affairs Specialist

Placements24; Mossel Bay; Hybrid; ZAR 600,000 - 1,000,000; Full time

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

Skills

Regulatory affairs

Communication skills

Remote work

Dossier submission

Project management

Education

Bachelor's degree in Pharmacy, Chemistry, or Biology

Master's degree preferred

Job description

About the Role

Our client is seeking a highly organized and knowledgeable Remote Pharmaceutical Regulatory Affairs Specialist to join their global team. This fully remote position is integral to ensuring compliance with the complex and ever-evolving regulatory landscape of the pharmaceutical industry worldwide. You will be responsible for preparing, reviewing, and submitting regulatory documentation, liaising with health authorities, and providing strategic regulatory guidance to product development teams. The ideal candidate is adept at navigating international regulatory requirements and possesses excellent communication skills for effective remote collaboration.

Key Responsibilities

• Prepare and compile high-quality regulatory submission dossiers (e.g., NDAs, MAAs, variations) for submission to global health authorities.
• Review and approve labeling, promotional materials, and other regulated content to ensure compliance.
• Liaise with regulatory agencies, responding to queries and managing the submission process through approval.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Monitor regulatory intelligence and advise internal teams on changes in regulatory requirements.
• Maintain regulatory databases and ensure accurate record-keeping of all regulatory activities.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field; Master's degree preferred.
• Minimum of 4 years of experience in Pharmaceutical Regulatory Affairs .
• Strong understanding of global regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Proven experience in preparing and submitting various regulatory dossiers.
• Excellent written and verbal communication skills, with a high degree of accuracy.
• Ability to work independently and manage multiple projects effectively in a remote setting.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Flexible working hours and a fully remote work arrangement.
• Generous professional development budget for training and certifications.
• A supportive and collaborative international team environment.