Responsible Pharmacist & Medical Manager

Guerbet; Johannesburg; Vor Ort; ZAR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Guerbet South Africa seeks a Responsible Pharmacist & Medical Manager to lead Regulatory, Medical Affairs, Quality, Pharmacovigilance and Compliance. You will act as the company's Responsible Pharmacist and primary medical advisor, overseeing quality, safety and regulatory activities across SA and selected export markets.

You will manage internal teams and external partners to ensure effective regulatory, medical and quality operations, with a focus on compliance, product quality and patient

Qualifikationen

• Pharmacy degree and registration with the SAPC required.
• Proven experience as Responsible Pharmacist or similar.
• Experience in Regulatory Affairs, Quality Assurance or GMP environments.

Aufgaben

• Act as the designated Responsible Pharmacist for Guerbet South Africa and ensure compliance with SA pharmaceutical regulations.
• Lead Regulatory Affairs activities including registrations, life-cycle management and inspections (SAHPRA).
• Serve as medical and scientific expert, provide information to healthcare professionals and internal stakeholders.

Kenntnisse

Regulatory Affairs

Quality Assurance

GMP

Medical Affairs

Leadership

Ausbildung

Pharmacy degree

Jobbeschreibung

About the role

As Responsible Pharmacist & Medical Manager, you will lead Regulatory, Medical Affairs, Quality, Pharmacovigilance and Compliance activities for Guerbet South Africa, ensuring full compliance with South African pharmaceutical legislation and regulatory requirements. You will act as the company's Responsible Pharmacist, serve as the primary medical and scientific advisor, and oversee quality and patient safety processes across South Africa and selected Southern African export markets.

You will also manage internal teams and external service providers, ensuring the effective delivery of regulatory, medical and quality operations.

Key Responsibilities

• Act as the designated Responsible Pharmacist for Guerbet South Africa, ensuring full compliance with applicable pharmaceutical, medical device and healthcare regulations across South Africa and relevant export markets.
• Lead Regulatory Affairs activities, including product registrations, life-cycle management, dossier maintenance, license renewals and interactions with regulatory authorities such as SAHPRA and other relevant health authorities.
• Serve as the company's medical and scientific expert, providing medical information and scientific support to healthcare professionals, customers and internal stakeholders.
• Develop and review scientific materials, ensure the accuracy and compliance of medical communications, and deliver training to commercial teams on products, clinical evidence and imaging techniques.
• Build and maintain relationships with key opinion leaders, healthcare institutions and external experts to support medical and scientific initiatives.
• Support the planning, execution and oversight of clinical studies, post-marketing studies and investigator-sponsored research activities when applicable.
• Lead Quality Assurance activities, including GMP/GDP compliance, quality management systems, audit readiness, supplier oversight, batch release activities and continuous improvement initiatives.
• Ensure inspection readiness and act as the primary contact during regulatory, quality and pharmacy inspections.
• Oversee Pharmacovigilance and Materiovigilance activities, ensuring timely reporting, risk management, patient safety monitoring and compliance with local and global requirements.
• Manage and oversee third-party service providers, contractors and distribution partners, ensuring appropriate quality agreements, performance standards and regulatory compliance.
• Provide strategic leadership across Regulatory, Medical, Quality and Safety functions, supporting business growth while maintaining the highest standards of compliance, product quality and patient safety.
• Lead, coach and coordinate internal team members and external partners to ensure efficient execution of operational and compliance responsibilities across the territory.
• Act as the designated Local Person Responsible for Pharmacovigilance (LPPV), ensuring full compliance with local pharmacovigilance requirements, including adverse event reporting, safety monitoring, risk management activities and implementation of global and local pharmacovigilance processes.
• Serve as the company's Authorised Representative for Medical Devices, ensuring compliance with applicable South African medical device regulations and acting as the primary regulatory contact for medical device-related matters with relevant health authorities.

Requirements

• Pharmacy degree and registration with the South African Pharmacy Council (SAPC).
• Previous experience as a Responsible Pharmacist.
• Minimum 5 years' experience in the pharmaceutical industry, with exposure to Regulatory Affairs, Quality Assurance and/or GMP environments.
• Previous experience in Medical Affairs or Medical Advisory, including scientific engagement with healthcare professionals, medical information activities and provision of scientific support to internal and external stakeholders.
• Experience in Pharmacovigilance and/or Medical Device regulatory activities would be considered a strong advantage.
• Experience interacting with SAHPRA and regulatory inspections is an advantage.
• Strong communication, stakeholder management and leadership skills.
• Fluent English, written and spoken.