- CTD/eCTD Preparation: you will be responsible for preparing Common Technical Document and electronic common technical document(eCTD) submissions.
- CMC Document Evaluation: Evaluate chemistry, manufacturing and controls (CMC) documents to ensure compliance with regulatory requirements.
- Collaboration: work closely with cross-functional teams to prepare for regulatory submissions and inspections.
Bachelor degree of Pharmacy or Science .Experience required from (1 : 3) years in the same role .Expertise in CTD Preparation ensuring accurate and comprehensive documentation.Regulatory familiarity: understand regulations from various authorities, including the EDA, SFDA and relevant African and EMA .Familiar with eCTD.Pharmaceutical Industry experience is mandatory .Professional Communication skills . Immediate hiring is highly preferred .6th October city resident & nearby are preferred .