Regulatory Affairs Pharmacist
Job Description
Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.
We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.
The main purpose of the Regulatory Affairs Pharmacist to prepare and submit medicine registration applications to various regulatory authorities outside South Africa in accordance with regulatory requirements of the relevant country. To maintain these registration applications subsequent to registration approval.
Preparing and submitting medicine registration applications for imported and locally made products in foreign countries. Maintaining existing product registrations in foreign countries. Responding to any deficiency letters or requests for information from the foreign countries. Checking of printed packaging specifications and proofs relevant to these registrations. Provision of product registration information on request by the Site Responsible Pharmacist and Export Marketing Managers. Assisting the Export Marketing Department with tender information relevant to the company. Preparing documents for international company registration in various territories. Maintaining the international registration product list. Assist with Batch Release when necessary From time to time, carry out other jobs within the factory /department, consistent with the grade qualification and training of the incumbent.
B. Pharm / Dip. Pharm. Registered Pharmacist with South African Pharmacy Council. 2-5 years Industrial Pharmaceutical Regulatory Affairs experience GMP, GWP and GDP Principles * Understand quality investigation requirements (risk assessments, deviations, OOS, change controls)
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Job Detail
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Job IdJD1503227
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationPort Elizabeth, EC, ZA, South Africa
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EducationNot mentioned