Regulatory Affairs Specialist - Hybrid, Global Compliance

Msd South Africa; Gauteng; Hybrid; ZAR 300 000 - 400 000; Full time

Job summary

A leading pharmaceutical company in South Africa is seeking a Regulatory Affairs professional to ensure timely preparation and submission of Marketing Authorization applications. The ideal candidate should have a BPharm or equivalent, with 1-2 years of experience in regulatory environments, ideally within Sub-Sahara Africa. This role requires effective communication skills and the ability to relate well with internal and external stakeholders. The position is full-time with hybrid work arrangements.

Qualifications

• 1 - 2 years' experience in the regulatory environment is ideal.
• Experience working in Sub-Sahara Africa is advantageous.
• Understand how the department interacts with internal and external groups.
• Communicate effectively, both verbally and in writing.

Responsibilities

• Ensure timely preparation and submission of Marketing Authorization applications.
• Maintain assigned products through timely submission of variations and renewals.
• Manage quality labelling translation and artwork.
• Support agency interactions for seamless submissions and approvals.

Skills

Accountability

Adaptability

Detail-Oriented

Pharmaceutical Regulatory Affairs

Regulatory Compliance

Regulatory Submissions

Education

BPharm or other life science

Job description

A leading pharmaceutical company in South Africa is seeking a Regulatory Affairs professional to ensure timely preparation and submission of Marketing Authorization applications. The ideal candidate should have a BPharm or equivalent, with 1-2 years of experience in regulatory environments, ideally within Sub-Sahara Africa. This role requires effective communication skills and the ability to relate well with internal and external stakeholders. The position is full-time with hybrid work arrangements.