Global Regulatory Affairs Specialist — Dossier & Compliance

Placements24; Gauteng; On-site; ZAR 700,000 - 950,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Professional development opportunities

Job summary

Placements24 is seeking a Regulatory Affairs Specialist based in Tembisa, Gauteng to manage regulatory submissions and ensure compliance with SAHPRA and international requirements. The role involves close collaboration with R&D, Manufacturing, and Marketing to support product registrations and lifecycle management.

The ideal candidate has a strong background in pharmaceutical regulatory affairs, excellent communication skills, and a meticulous approach to documentation to help drive timely

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field required.
• Minimum 5 years of pharmaceutical regulatory affairs experience.
• Experience preparing and submitting regulatory dossiers to health authorities.
• Strong knowledge of SAHPRA and international regulatory requirements.
• Excellent written and verbal communication with meticulous attention to detail.
• Proficiency with regulatory information management systems is an advantage.

Responsibilities

• Prepare, compile, and submit regulatory dossiers for NDAs, variations, and renewals.
• Ensure submissions comply with local and international guidelines (SAHPRA, FDA, EMA).
• Liaise with regulatory authorities to respond to queries and facilitate approvals.
• Monitor regulatory landscape and assess impact on products and strategies.
• Review product labeling, promotional materials, and advertising for compliance.
• Maintain regulatory databases and ensure documentation is up-to-date.
• Collaborate with R&D, Manufacturing, and Marketing to gather submission information.
• Provide regulatory guidance and support to cross-functional teams.
• Manage post-approval commitments and lifecycle management activities.

Skills

Regulatory submissions

Documentation accuracy

Stakeholder communication

Regulatory knowledge

Project management

Analytical skills

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Life Sciences

Bachelor's degree in Chemistry

Master's degree

Tools

Regulatory information systems

Job description

Placements24 is seeking a Regulatory Affairs Specialist based in Tembisa, Gauteng to manage regulatory submissions and ensure compliance with SAHPRA and international requirements. The role involves close collaboration with R&D, Manufacturing, and Marketing to support product registrations and lifecycle management.

The ideal candidate has a strong background in pharmaceutical regulatory affairs, excellent communication skills, and a meticulous approach to documentation to help drive timely