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REGULATORY AFFAIRS ASSISTANT ADMINISTRATOR

Duties & Responsibilities Typing of standard operating procedures, filing, photocopying and faxing; Control of flow of promotional material and master documentation; Page numbering, date stamping and photocopying of registration documents; Completion of sections of the registration application form/dossier to be screened by the MCC (depending on current experience level); Transporting correspondence to the MCC and other third parties as deemed necessary; Typing of resolution templates and forwarding to manufacturer; Ordering of stationery; Ordering of product samples for laboratory analysis; Monitor changes in MCC and related websites and printing in accordance with MCC guidelines; and Updating of all registration and other status reports. Ensure familiarity with latest requirements of CTD dossier. Compilation of Type A,B, C amendments to the MCC; Submission of ongoing stability data to the MCC; Pre-screening of new dossiers in order to meet the MCC requirements; Review batch manufacturing documents and validation protocols prior to approval; Compilation of sections of a generic registration dossier; Responding to MCC queries; Desired Experience & Qualification Matric. Minimum 5 years exposure in Regulatory Affairs. Dealing with the MCC. Advanced understanding of Microsoft Office (Excel, Word and Outlook) Experience in MS Project an advantage Highly Computer Literate. connect@accotech.co.za

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