Responsible Pharmacist – Quality Assurance, Regulatory, QPPV

🕒 May 21

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BeOne Medicines

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10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Develop regulatory filing strategies • Manage submissions and approvals • Maintain licenses and review promotional materials • Act as the Local Qualified Person for Pharmacovigilance (QPPV) • Ensure patient safety and case reporting • Oversee GMP/GDP compliance and manage local quality management systems • Handle deviations and recalls • Support product launches and post-marketing quality activities

🎯 Requirements

• A Bachelor of Pharmacy degree • Registration with the South African Pharmacy Council • At least eight years’ experience in regulatory affairs and quality assurance • Proficiency in electronic quality systems and regulatory dossier requirements • 24-hour availability for SAHPRA • Strong identification with BeiGene's values and loyalty to the company • Valid driver’s license • Fluency in both verbal and written English • Standard Computer Skills required (MS Office)

🏖️ Benefits

• Health insurance • Professional development opportunities