RA Pharmacist / Scientist - JHB

RA SCIENCTIST / PHARMACIST

Pharmaceutical Sector

JHB

Leading pharmaceutical company seeks a suitably qualified / experienced Regulatory Scientist / Pharmacist to join their dynamic team and to manage the registration process for allocated therapeutic categories for new and existing products, including liaison with the relevant Health Authorities and third parties
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Minimum Requirements:

· Bachelor of Pharmacy Degree or relevant B Sc. Degree (post-graduate level

· Registered with the SAPC (South African Pharmacy Council)

· Min 2 years’ Regulatory experience in the pharmaceutical sector

· Able to perform all standard registration processes under specialist guidance

· Computer literate and able to effectively use Excel and Word and PowerPoint

· Able to perform all aspects of registration processes

· Professional and presentable

· Effective written and verbal communication skills

· Highly organized and good planning skills

· Self-discipline and effective administration skills

· Highly accurate and has good attention to detail

· Positive attitude

· Self-motivated

· Work well as part of a larger team


Key Responsibilities:

Product registration

· Conduct due diligence on new dossiers from overseas and local suppliers and compile for submission as and when required

· Compile and submit all required dossier amendments

· Identify and maintain updates on existing products based on MCC guidelines and allocated priorities

· Interact on a regular basis with overseas affiliates, third parties and contractors on dossier related activities

· Compile and submit all MCC recommendations/safety updates and amendments within agreed and specified time limits

· Submit dossiers and relevant amendments in neighbouring countries

· General management of the dossier/clinical documentation in the format as prescribed by MCC guidelines


Technical / Compliance activities

· Assist with annual product reviews

· Assist with technical queries internally and with the guidance of line management, externally

· Assist with answering relevant Pharmacovigilance and Technical queries

· Assists with review and approval of batch release documents

· Assists with periodic internal audits

· Manage and monitor the Change Control Process effectively


Packaging and marketing materials

· Review and assist with approval of printed packaging components and promotional material as and when required.

· Assist with compilation, review and approval of advertising material as and when required

· Ensure all printed material (including web based), complies with the Marketing Code of Conduct and MCC requirements


Document management

· Ensure the EDMS is current and up to date and in line with printed dossiers.

· Ensure dossiers are in line with MCC requirements and assists with the maintenance thereof and preparations for eCTD-submissions