Regulatory Affairs Leader: Drug Registration & Compliance

Hire Resolve; Midrand; Vor Ort; ZAR 1.200.000 - 1.800.000; Vollzeit

Benefits dieser Stelle

Negotiable salary

Career advancement opportunities

Zusammenfassung

A leading recruitment agency is seeking a Regulatory Affairs Manager to ensure compliance and manage product registration processes in Midrand, Gauteng. The successful candidate will lead regulatory strategies, manage documentation, and work closely with various stakeholders. A B. Pharm degree and over 10 years of experience in Regulatory Affairs are essential, along with pharmacovigilance expertise and a solid understanding of South African regulations. This position offers a negotiable salary and opportunities for career advancement.

Qualifikationen

• Minimum of 10 years experience in Regulatory Affairs with human medicine and biologicals.
• Competent in eCTD submissions and familiar with ZAZIBONA processes.
• Experience with product registration and dossier maintenance.

Aufgaben

• Lead and manage the regulatory affairs processes.
• Ensure all documents comply with regulatory standards.
• Provide input on the regulatory strategy aligned with business objectives.

Kenntnisse

Regulatory documentation compliance

Pharmacovigilance experience

Knowledge of South African regulations

Microsoft Office Suite proficiency

Ausbildung

B. Pharm (Bachelor of Pharmacy)

Registration with the South African Pharmacy Council (SAPC)

Jobbeschreibung

A leading recruitment agency is seeking a Regulatory Affairs Manager to ensure compliance and manage product registration processes in Midrand, Gauteng. The successful candidate will lead regulatory strategies, manage documentation, and work closely with various stakeholders. A B. Pharm degree and over 10 years of experience in Regulatory Affairs are essential, along with pharmacovigilance expertise and a solid understanding of South African regulations. This position offers a negotiable salary and opportunities for career advancement.