Minimum requirements
· Bachelor of Pharmacy degree and current registration as a pharmacist with the South African Pharmacy Council, in good standing.
· Eligibility and appropriate experience to be appointed as Responsible Pharmacist for the company’s licensed activities.
· At least 10 years of relevant pharmaceutical or healthcare industry experience, including substantial experience in regulatory affairs, quality, medical affairs or pharmacovigilance.
· At least 3 years in a leadership role with accountability for people, priorities, governance and cross-functional delivery.
· Demonstrated knowledge of South African medicines and pharmacy legislation, health-product advertising requirements, Good Manufacturing Practice and Good Distribution Practice.
· Experience working with a mixed portfolio that may include prescription medicines, over-the-counter medicines, medical devices, complementary medicines, cosmetics or food supplements.
· Experience engaging with health authorities and managing compliance across South Africa; African market or regional experience is strongly preferred.
· Ability to travel and to act with the independence, judgement and professional accountability expected of a Responsible Pharmacist.
Core accountabilities
Responsible Pharmacist and Legal Compliance
*Ensure compliance with all pharmacy, medicines and regulatory requirements while fulfilling Responsible Pharmacist duties.
*Maintain oversight of licensed activities, regulatory records and inspections, and escalate significant compliance or safety risks.
Science Affairs Strategy and Leadership
*Lead and implement the Science Affairs strategy aligned with business objectives, compliance and patient safety.
*Develop and manage the Regulatory Affairs, Pharmacovigilance and Quality teams while driving performance and capability.
Regulatory Affairs and Market Access Enablement
*Oversee registrations, renewals, variations and regulatory activities across South Africa and relevant African markets.
Quality and Supply-Chain Governance
*Ensure effective quality management systems and compliance with GMP and GDP requirements.
Pharmacovigilance and Patient Safety
*Provide governance and oversight of pharmacovigilance systems, adverse event reporting and safety activities.
Governance of Promotional Partner
*Oversee third-party medical and promotional activities to ensure compliance with legal, quality and contractual requirements.
Advertising, Promotional Compliance and Governance
*Review and approve promotional materials, advertising and scientific claims in line with regulations and industry codes.
Cross-Functional and External Stakeholder Leadership
*Act as a strategic business partner, providing regulatory, quality and scientific input to support decision-making.
Decision Rights and Accountability
*Authorise, stop or escalate activities that pose legal, quality, safety or compliance risks
Je me crée un espace candidat
