Regulatory Affairs Officer
Naratech pharmaceutical consultancy
مجموع سنوات الخبرة :0 years, 6 أشهر
Preparing CTD files for pharmaceutical Products according to SFDA Guidelines .
Preparing CTD files for Herbal Products according to SFDAGuidelines .
Bioequivilance studies monitoring in the Bioequivilnace centres; (PRU, JCPR ) and preparing studies moniroring reports .
Setting specifications for raw, intermediate and finished products.
Dealing with US Pharmacopeia, European Pharmacopeia and British pharmacopeia .
Communications and negotiations with the JFDA, SFDA regarding drug registration and submissions and writing formal letters to different orginaztions .
keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to.
collecting, collating and evaluating scientific data that has been researched by colleagues.
Conducting pre-formulation studies; literature surveys
Conferences complete organization and preparation and comuunication with all related parties .
Conducting pre-formulation studies including; literature surveys and sourcing for raw materials, and performing pre-formulation work.
Performing lab scale studies and essential similarity studies with brand products.
Set up equipment used in making formulations.
Maintain detailed daily formulation records and raw material sampling records.
Restock raw materials and keep track of R & D equipment.
Fill products in proper containers & label accordingly for clients, QC, stability testing or other forms of testing.
Executing pilot scale batches and related In process control and following up with all related analytical and stability issues.
Communicating with the Pharmaceutical Research Unite about samples sent for bioequivalence studies and following up with them.
Setting specifications for raw, intermediate and finished products.
Preparing products master formulas.
Dealing with US Pharmacopeia, European Pharmacopeia and British pharmacopeia .
Drug master files revision and CTD3 files preparation .
Writing official letters to the JFDA and Clearance house including preparing batches distribution letters for active and inactive raw materials and negotiating with them.
as a medical representative for Roche in community pharmacies.
courses: 3.13 Tawjihi – Sands National Academy School - 2009 ( 96.5)