Regulatory Affairs Specialist — MA Submissions & Labelling

Merck & Co., Inc.; Gauteng; On-site; ZAR 300 000 - 500 000; Full time

Job summary

A leading global pharmaceutical company is seeking a Regulatory Affairs professional in South Africa to ensure the timely submission of Marketing Authorization applications and maintain compliance with local regulations. The ideal candidate will hold a BPharm or equivalent and have experience in regulatory affairs, preferably in Sub-Sahara Africa. This role involves collaboration with internal and external stakeholders and a strong attention to detail in regulatory processes.

Qualifications

• 1 - 2 years' experience in the regulatory environment is ideal.
• Experience working in Sub-Sahara Africa is advantageous.
• Proficient in English and in using PCs for word processing, spreadsheets, databases, and internet.

Responsibilities

• Ensures timely preparation and submission of Marketing Authorization applications.
• Maintains licenses for assigned products and regulatory compliance.
• Participates in establishing and maintaining Standard Operating Procedures.

Skills

Accountability

Adaptability

Detail-Oriented

Pharmaceutical Regulatory Affairs

Regulatory Compliance

Education

BPharm or other life science equivalent

Job description

A leading global pharmaceutical company is seeking a Regulatory Affairs professional in South Africa to ensure the timely submission of Marketing Authorization applications and maintain compliance with local regulations. The ideal candidate will hold a BPharm or equivalent and have experience in regulatory affairs, preferably in Sub-Sahara Africa. This role involves collaboration with internal and external stakeholders and a strong attention to detail in regulatory processes.