Remote Regulatory Affairs Specialist — Dossiers & Compliance

Placements24; East London; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Fully remote work environment

Health and wellness benefits

Professional development support

Job summary

Placements24 is seeking a meticulous Regulatory Affairs Specialist to join our established team in a fully remote role. You will monitor regulatory changes, prepare submission dossiers, and liaise with regulatory authorities to secure and maintain product approvals.

The ideal candidate will have a strong understanding of regulatory landscapes and a proven track record navigating complex processes, with at least five years of experience in regulatory affairs.

Qualifications

• Bachelor's or Master's degree in a relevant scientific, technical, or legal field.
• Minimum of 5 years of experience in regulatory affairs in a regulated industry.
• Deep knowledge of regulatory submission processes and requirements.
• Strong analytical skills and meticulous attention to detail in documentation and review.
• Excellent written and verbal communication skills for presenting complex information clearly.

Responsibilities

• Monitor and interpret regulatory requirements, standards, and guidelines for products and operations.
• Prepare, review, and submit regulatory dossiers and applications to health authorities and other regulators.
• Manage lifecycle of regulatory approvals including post-market surveillance and variation filings.
• Collaborate with R&D, Quality, Marketing to ensure regulatory compliance in development and labeling.
• Represent the company in interactions with regulatory agencies and industry groups.
• Stay updated on regulatory changes and advise on strategic implications.

Skills

Regulatory affairs

Regulatory change monitoring

Analytical skills

Communication skills

Attention to detail

Regulatory submissions

Education

Bachelor's or Master's degree in a relevant field

Tools

Regulatory information management systems

Microsoft Office

Job description

Placements24 is seeking a meticulous Regulatory Affairs Specialist to join our established team in a fully remote role. You will monitor regulatory changes, prepare submission dossiers, and liaise with regulatory authorities to secure and maintain product approvals.

The ideal candidate will have a strong understanding of regulatory landscapes and a proven track record navigating complex processes, with at least five years of experience in regulatory affairs.