Remote Regulatory Affairs Specialist

Placements24; Centurion; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Generous paid time off

Home office stipend

Health insurance

Job summary

Placements24 is seeking a Remote Regulatory Affairs Specialist to support a global team from Centurion, Gauteng. You will ensure compliance with national and international pharmaceutical regulations, manage regulatory dossiers, and stay ahead of evolving regulatory landscapes.

The role requires a Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field, at least 4 years in regulatory affairs, and excellent English communication.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences or related field; advanced degree preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting drug registration dossiers.
• In-depth knowledge of regulatory requirements in SA, Europe and USA.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD format) to health authorities (SAHPRA, FDA, EMA).
• Monitor regulatory guidelines and advise on their impact on products and strategies.
• Maintain regulatory documentation with accuracy and compliance.
• Liaise with R&D, Manufacturing, Marketing and external regulatory bodies.

Skills

Regulatory affairs

Dossier submission

Regulatory intelligence

Communication

Education

Bachelor’s degree in Pharmacy, Chemistry, Life Sciences

Job description

About the Role

Our client is actively seeking a highly skilled and motivated Remote Regulatory Affairs Specialist to join their global team, supporting operations from Centurion, Gauteng . This position is fully remote, offering the flexibility to work from anywhere within South Africa. You will be responsible for ensuring compliance with national and international pharmaceutical regulations, managing the submission of regulatory dossiers, and maintaining up-to-date knowledge of evolving regulatory landscapes. This role is essential for navigating the complexities of pharmaceutical approvals and market access, contributing directly to the company's strategic goals.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD format) to health authorities like SAHPRA, FDA, and EMA.
• Monitor and interpret regulatory guidelines and advise on their impact on company products and strategies.
• Maintain regulatory documentation, ensuring accuracy, completeness, and adherence to compliance standards.
• Liaise effectively with internal departments (R&D, Manufacturing, Marketing) and external regulatory bodies.
• Manage post-approval changes, variations, and renewals for existing product registrations.
• Conduct regulatory intelligence gathering and report on emerging trends and requirements.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting dossiers for drug registration.
• In-depth knowledge of regulatory requirements in key markets (South Africa, Europe, USA).
• Excellent written and verbal communication skills, with a strong command of English.
• Ability to work autonomously, manage multiple projects, and meet tight deadlines in a remote setting.

Benefits

• Competitive salary and performance-based incentives.
• Generous paid time off and flexible working hours.
• Home office setup stipend.
• Comprehensive health, dental, and vision insurance coverage.
• Opportunities for continuous professional development and international collaboration.