JENI JOHN

Dispensing Pharmacist

• Job Details:Reviewing and executing physician’s prescriptions checking their appropriateness and legality. Organizing the pharmacy in an efficient manner to make the identification of products easier and faster. Maintaining full control over delivering, stocking and labeling medicine and other products.

Regulatory Affairs Executive

• Job Details:Coordinating and collecting details for preparation of regulatory documentation/dossiers for submission to the regulatory authorities (MENA) - non CTD/CTD & eCTD dossiers. Timely registration of company's products and compiling materials required for renewal of product licenses. Establishing and maintaining system for tracking changes in documents submitted to the regulatory authorities (MENA). Actively participating in evaluation of regulatory compliance of documents, products, process, test methods. Ensuring that company's products comply with the regulations of MENA. Keeping abreast of international legislation, guidelines and customer practices in all countries. Monitoring and setting timelines for license variations and renewal approvals. Handle queries appropriately and ensuring the submission of response on time.

Research & Development Executive

• Job Details:Preparing of MFRs, MPRs, scale-up BMR, BPR, process validation protocol, bill of material, packaging material specification, raw material specifications, hold time study protocol, stability protocol, change control form handling, in-process, finished, shelf life specifications. Well versed with ERP systems. Perform preformulation, compatibility, photostability, in-use stability (liquids) and stress study of new formulation. Planning and execution of scale-up and exhibit batches for regulatory and UAE market. Prepare product development report. Continuous follow up with various departments, quality control, quality assurance, marketing, supply chain and stores. Well versed with packaging material development.