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Pfizer South Africa’s vision of "living our full potential in striving for a healthier Southern Africa" forms part of Pfizer’s ethos whereby every Southern African should have access to quality healthcare. At Pfizer South Africa we are dedicated to the improvement of human life and the battle against disease & disability. We have...
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Summary: The country-based Regulatory Affairs Pharmacist (RAP) will provide regulatory support for the Pfizer Biopharmaceutical Group portfolio including registration, pre-approval and post-approval activities. The country-based RAP supports and reports to the Country Head of Regulatory Affairs (HRA). The country-based RAP supports the Country HRA with the development and execution of regulatory strategies and plans for the country. The country-based RAP will support broader country/hub projects as required by the HRA.
Job Responsibilities:
Compile and submit new product applications, clinical trial applications, generic applications, new indications or line extension applications to the relevant HA’s/BoH’s, ensuring that local registration requirements are fulfilled.
Qualifications:
Experience:
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
Governance & internal organization
Product Complaints
Temperature excursion
Returns
Qualifications/ Skills
Qualifications and Experience
Years of experience: 1-5 years in the Pharmaceutical or related regulated industry
Technical skills
Soft skills/ Management & Leadership Skills
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