Regulatory Affairs Specialist – Pharma Submissions & Lifecycle

Gen-Eye (Pty) Ltd; Midrand; Vor Ort; ZAR 480.000 - 600.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Midrand, Gauteng is looking for a Regulatory Affairs Specialist to manage regulatory submissions and lifecycle activities for pharmaceutical products. Candidates should have a Bachelor of Pharmacy and at least three years of experience in Regulatory Affairs. This full-time role requires proficiency with DocuBridge and a strong focus on compliance and communication. The successful applicant will contribute to bringing life-changing medicines to market efficiently.

Qualifikationen

• Minimum 3 years in Regulatory Affairs.
• Skilled in managing dossier sequences and lifecycle activities.
• Experience with SAHPRA portal submissions.

Aufgaben

• Initiate and manage timely registration processes for new product submissions.
• Ensure approval of all medicine registration applications with relevant authorities.
• Build and maintain strong relationships with regulatory authorities.

Kenntnisse

Proficiency with DocuBridge

Strong communication skills

Problem-solving abilities

Attention to compliance and accuracy

Familiarity with biological products

Ausbildung

Bachelor of Pharmacy (BPharm)

MSc

Tools

DocuBridge

Jobbeschreibung

A leading pharmaceutical company in Midrand, Gauteng is looking for a Regulatory Affairs Specialist to manage regulatory submissions and lifecycle activities for pharmaceutical products. Candidates should have a Bachelor of Pharmacy and at least three years of experience in Regulatory Affairs. This full-time role requires proficiency with DocuBridge and a strong focus on compliance and communication. The successful applicant will contribute to bringing life-changing medicines to market efficiently.