Hybrid Regulatory Affairs Specialist - Submissions

MSD; Midrand; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading global healthcare company in Midrand is seeking a Regulatory Affairs professional to manage Marketing Authorization applications and maintain product compliance. The ideal candidate will have a BPharm or equivalent, experience in regulatory environments, and strong communication skills. This role emphasizes timely submissions and compliance with local regulations in a hybrid work setting.

Qualifications

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

Responsibilities

• Ensure timely preparation, submission, and follow-up of new Marketing Authorization applications.
• Maintain assigned, authorized products through timely submission of variations and renewal applications.
• Provide timely preparation and maintenance of local regulatory documents.

Skills

Accountability

Adaptability

Detail-Oriented

Management Process

Pharmaceutical Regulatory Affairs

Regulatory Affairs Management

Regulatory Compliance

Regulatory Labeling

Regulatory Reporting

Regulatory Submissions

Education

BPharm or other life science or equivalent

Job description

A leading global healthcare company in Midrand is seeking a Regulatory Affairs professional to manage Marketing Authorization applications and maintain product compliance. The ideal candidate will have a BPharm or equivalent, experience in regulatory environments, and strong communication skills. This role emphasizes timely submissions and compliance with local regulations in a hybrid work setting.