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Cape Town
milestone tracking, and resource management.
• Act as a bridge between project management and R&D and CMC teams, facilitating clear and efficient communication.
• Assist with data collection, documentation, and compliance with scientific standards...
Curiska-Johannesburg
CMC/P&A variations, and oversee license renewals with authorities. Audits: Manage internal and external audits. Pharmacovigilance: Report and follow up on ADRs; provide local staff training. QMS: Implement and maintain the Quality Management System...
Emporium Human Capital-Midrand
collaboration with internal and external stakeholders to assess regulators submissions requirements
• Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
• for variations (CMC...
Emporium Human Capital-Johannesburg South
submissions requirements Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines for variations (CMC & Labelling), Renewals, Artwork updates etc. Update and maintain databases...
Emporium Human Capital-Midrand
for variations (CMC & Labelling), Renewals, Artwork updates etc.
• Update and maintain databases, trackers and systems for all regulatory related activities.
• Quality Management System: Comply with all requirements of Quality Management System to ensure Good...
Johannesburg
with internal and external stakeholders to assess regulator's submissions requirements
• Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
for variations (CMC & Labelling...
Emporium Human Capital-Midrand
stakeholders to assess regulators submissions requirements
• Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines for variations (CMC & Labelling), Renewals, Artwork updates etc...
Somewhere-South Africa
etc.)
• Familiarity with CMC, non-clinical, and clinical modules a plus.
• Ability to draft cover letters and complete FDA forms.
• Experience with IND (Investigational New Drug) and NDA (New Drug Application) submissions.
• ECTD publishing software...
recruitcrm.io -
Emporium Human Capital-Midrand
for variations (CMC & Labelling), Renewals, Artwork updates etc.
• Update and maintain databases, trackers and systems for all regulatory related activities.
• Quality Management System: Comply with all requirements of Quality Management System to ensure Good...
Datonomy Solutions-Cape Town
components is desirable. Create & maintain universes & business layer through IDT, BOBJ report, building, maintenance, scheduling & publications with Web Intelligence and CMC.
• Object- orientated /object functional scripting languages (python, Java, Shell...
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