Regulatory Affairs Assistant

Regulatory Affairs Assistant

Placement Point (Pty) Ltd

Regulatory Affairs Assistant

Details of the offer

A dynamic company based in Parktown is looking for aRegulatory Affairs Assistant
Responsible for providing administrative and technical assistance to the Regulatory Affairs division
Compile and update SOP’s as per MCC requirements and within an agreed timeframe
Responsible for proof reading artwork and Promotional material in line with approved dossier package insert
Liaise with printing agents to ensure accurate and timeous printing of packaging material

Assist with the Operations and Administration of the Regulatory Affairs Department:
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
Updating of all registration and other status reports
Ensure familiarity with latest requirements of CTD dossier

Responsible for MCC Submissions:
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
Updating the Applicant Master files as per MCC requirements
Docubridge - Pulling in working documents, creating submission for publication

Communication with MCC and third parties:
Tracking status of product evaluation within different units at MCC and provide feedback in order to obtain approval
Establish contacts within MCC to improve and enhance relationship building
Establish contacts with manufacturers in order to receive information timeously

Source: Careers24



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