Regulatory Affairs Manager & Responsible Pharmacist for Southern Africa (SACAM) at Galderma

Job Description

The role focuses on leading and executing all Regulatory Affairs, Quality, Pharmacovigilance. Medical Information, and HCP Compliance priorities for all product classes (medicinal products, medical devices, cosmetics) across the SACAM country cluster covering Southern Africa (South Africa, Namibia, Botswana), Central Africa (Kenya), and Mauritius), in partnership with promotional distributors, functional service providers, and agents, where applicable.

Job Responsibilities

• Responsible Pharmacist and Regulatory Affairs Manager responsible for GMP, efficacy and safety of our medicinal products in Southern Africa
• Responsible for medicinal products in South Africa and Southern African countries for Galderma's license to Manufacture, Import or Export Medicines
• Authorized Representative for Galderma's license to Distribute Medical Devices for South Africa
• Regulatory Affairs: Lead, shape, drive and execute all Regulatory Affairs priorities for all product classes (medicinal products, medical devices, cosmetics) across Southern Africa.
• Lead and manage the entire registration process, ensuring approvals of new products, Renewals, manufacturing permits, import permits, and amendments to products.
• Lead regulatory strategy development to enhance speed to market for new product development, and lead execution.
• Ensure new license applications are submitted within agreed project timelines, and approvals are obtained as planned. Ensure compliance with, and maintenance of, existing licenses; ensure compliance with the Medicines and Related Substances Control Act, and the Pharmacy Act.
• Oversees quality assurance and quality control concerning all Galderma products, and GMP compliance. Provide strategic directions to the business, accountable for delivering project goals and aligning functional strategies with business needs.
• Lead interactions and negotiations with Health Authorities. Shape the regulatory environment, driving an agenda to create an external environment in which our portfolio can thrive. Build a network with external experts. Partnership with distributors and agents, where applicable
• Quality: Manage the Quality management System. Authorize the release for sale of conforming products. Manage deviations and change controls.
• Local QPPV & Local Safety Officer: Manage implementation and maintenance of the local Summary of PV System as required by the local regulation. Maintain PV Master File (PSMF). Collection and management of the Pharmacovigilance reports.
• HCP Compliance Officer: Oversee the effectiveness of the company’s compliance program and foster a culture of integrity and ethical business practices, providing guidance and support to the business functions in their day-to-day activities, and work collaboratively with senior management to disseminate a tone at the top and middle that reflects the company’s commitment to integrity. Ensure compliance with global standards.

Minimum Requirements

• 7 years’ experience with medicinal product registration in addition to retail/hospital or production pharmacy experience
• A minimum of 4 years’ experience as Responsible Pharmacist, responsible for GMP, efficacy and safety of medicinal products in South Africa, handling all aspects related to Quality & Pharmacovigilance, Medical Information, review and approval of marketing materials in conformity with the Code of Marketing, and interacting with Healthcare Professionals (HCPs) when needed.
• Registered with the South African Pharmacy Council for Galderma's 'Manufacturing Pharmacy' license, and responsible for medicinal products in front of the South African Department of Health
• Preferred additional regulatory experience with medical devices and cosmetics, and ideally experience in dermatology
• In-depth understanding of the pharmaceutical industry within SACAM, and strong connections with the South African Health Authorities (SAHPRA