Senior Regulatory Specialist - FSP (Johannesburg) - (Remote)
Currently, the position is hybrid office-based.
Accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
Experience required to be a fit for this role:
- Mandatory - experience in EC and RA submission (ideally, familiar with XML completion) – including initial submission and protocol amendments submission.
- Experience in independently preparing submissions (CTC supports with document collection) to both EC and RA.
- Experience in ICF preparation using templates.
- Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
- Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.)
- Experience in validation of translated documents.
We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.
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