Pharma Regulatory Affairs Specialist: Dossier & Compliance

Placements24; Centurion; Hybrid; ZAR 750,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Health and wellness benefits

Paid vacation

Professional development

Collaborative environment

Job summary

Placements24, on behalf of a respected pharmaceutical organization, seeks an experienced Regulatory Affairs Specialist to join its Centurion team. You will ensure products meet regulatory standards and manage dossiers for SAHPRA, FDA, and EMA.

You will collaborate with R&D, QA, and marketing, monitor regulatory changes, and guide lifecycle strategies, with a focus on accuracy, compliance, and timely submissions.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field.
• 4+ years of experience in pharmaceutical regulatory affairs.
• Experience in preparing and submitting regulatory dossiers (CTD).
• Thorough understanding of SAHPRA, FDA and EMA regulations and guidelines.
• Excellent written and verbal communication in English.

Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications, variations, and renewals to health authorities such as SAHPRA, FDA, and EMA.
• Ensure compliance with all applicable national and international pharmaceutical regulations, guidelines, and standards.
• Liaise effectively with regulatory agencies, responding to queries and managing communications during the review process.
• Maintain up-to-date knowledge of regulatory requirements and industry best practices.
• Develop and implement regulatory strategies for product lifecycle management, including post-approval changes and annual reports.
• Conduct regulatory intelligence activities to monitor changes in the regulatory environment and assess their impact on the business.
• Review promotional materials and product labeling to ensure regulatory compliance.
• Collaborate with R&D, Quality Assurance, Marketing, and other departments to provide regulatory guidance and support.
• Manage the archiving and maintenance of regulatory records and databases.
• Participate in regulatory audits and inspections as needed.

Skills

Regulatory affairs

Dossier preparation

Regulatory strategy

Regulatory liaison

Education

Bachelor's degree in Pharmacy

Master's degree or equivalent

Tools

Regulatory information management systems

Job description

Placements24, on behalf of a respected pharmaceutical organization, seeks an experienced Regulatory Affairs Specialist to join its Centurion team. You will ensure products meet regulatory standards and manage dossiers for SAHPRA, FDA, and EMA.

You will collaborate with R&D, QA, and marketing, monitor regulatory changes, and guide lifecycle strategies, with a focus on accuracy, compliance, and timely submissions.