Regulatory Affairs Pharmacist

SUMMARY:
A Leading Company is currently seeking a Regulatory Affairs Pharmacist to join their extraordinary team.

POSITION INFO:

Minimum Requirements:

• 3 – 5 years’ experience as a Regulatory Affairs Pharmacist
• Screening, compilation and registration of new multisource (generic) products in eCTD format for the South African market.
• Competency with, and administration of the DocuBridge programme (‘Power User’), to submit eCTD applications and ensure dossier life cycle management as per SAHPRA requirements.
• Maintenance of and submission of amendments to South African registered product dossiers (in compliance with SAHPRA requirements - includes dossier conversions).
• Communication with SAHPRA and other relevant health authorities.
• Communication with local and overseas 3rd party manufacturers, packers and laboratories.
• Review and approval of manufacturing master documents.
• Review and approval of printed packaging material (upon registration of a product to ensure compliance with the dossier and regulations).
• Review and approval of final printed packaging material artwork (for subsequent changes to the initial version).
• Competency with e-Submission requirements as per SAHPRA requirements for new and existing applications.
• Drafting, review and approval of regulatory SOPs and legal documents as required for an applicant.

Let us take your CAREER to the next level!                                           

Our innovative strategy and continuous streamlining of processes ensure we stand out from our competitors.

For more exciting positions visit our website www.higherintelligence.co.za or give the specialist recruitment consultant a call on JHB 011 -442-0633.

Please note if you have not received feedback within two weeks please consider your application unsuccessful.                                              

NB! This job is now closed. You can apply for other jobs by uploading your CV.