Pharmacy regulatory affairs jobs

As the Regulatory Affairs Specialist EAST AFRICA , you will be responsible for obtaining and maintaining regulatory approvals and in meeting of in country regulations for IVD s so to ensure Abbott products are compliant to meet appropriate in country regulations for all business units under Abbott Rapid Diagnostics for the region assigned. What You ll Do Product registrations Supports the prepara...

Review of labels following local HA guidelines and advise customers on the best compliance practices. Perform high-quality CMC review of technical documentation i.e. CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and Labelling documents, for filings with HA. Attend Pre-Submission meetings with the HA and prepare post-meeting package/minutes for internal, client, and HA records. Assist in t...

As the Regulatory Affairs Specialist EAST AFRICA , you will be responsible for obtaining and maintaining regulatory approvals and in meeting of in country regulations for IVD's so to ensure Abbott products are compliant to meet appropriate in country regulations for all business units under Abbott Rapid Diagnostics for the region assigned.What You'll DoProduct registrationsSupports the preparatio...

Legal Jobs In Kenya.Brief Job Description: Ensure that the company s products comply with the regulations in the Countries where they are distributed.Timely compilation and submission of registration dossiers for Kenya and other countries per required format and guidelines.Keep up to date with national and international legislation, guidelines, and customer practices.Collect, collate, and evaluat...

PRODUCT REGISTRATIONSSupports the preparation and timely completion of submission of registrations for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs for ARDX division for different business units - ID, CM and Tox for the assigned region.Participation on cross functional project teams to provide the required input that enables strategic guidance to ...

Ensures timely compilation of product registration dossiers/notification, using ZenGRC an internal tool for loading documentation requests. Ensures proactive compliance of Colgate products with all applicable regulations across the East Africa Region.Supports Technology and other internal stakeholders by delivering regulatory assessments.Keeps abreasts on latest regulatory developments in East Af...