Yousra Feroz Khan Rph. Email & Phone Number

Karachi, Pk

Karāchi, Sindh, Pakistan

I am working for International Regulatory affairs here. Directly dealing with the Registrations and renewals in Vietnam, Cambodia, Lao PDR,Uganda and Guatemala .My responsibilities include:• Complete knowledge of registration/renewal/variation guidelines of the specific country.• Company registration in exporting countries and its renewal.• Follow monthly work plan for exported products to be registered/renewed in exporting countries.• Communication with different departments for collection of data for regulatory purpose.• Review of provided documents (SMF, DMF, PD, BMR, In-process SOPS, PV, Specifications, testing methods, COA, Monographs, AMV, Stability)• To review and summarize data ensuring the regulatory compliance with exporting country’s guidelines.• To review and communicate QA Department (artwork section) for development of new Artwork as per country specific requirements.• To prepare and submit product’s registration/renewal dossier.• To initiate change control time to time on the basis of change in any regulatory impact on registered product according to country’s specific requirements.• To ensure implementation of change control within the company.• To prepare & submit variation application of registered product in respective countries as required.• To prepare CoPP/FSC for the product registration/renewal dossier in exporting countries.• To prepare NOC for dispatching of samples in exporting countries.• To prepare DHL for dispatching of dossiers (hard copy/CD) and samples.• International correspondence with consultants and distributors of respective countries.• To update monthly report of work in progress (WIP) for respective countries.

Karāchi, Sindh, Pakistan

• Desktop survey for New Generic Drug Products and search for the Innovator drug products• Literature study regarding the development of New Generic Drug product including FDA approvals, emc, MHRA, TGA, CMC data, Public Assessment Reports etc.• Development of New Generic Drug Product• Formulation Development & Manufacturing Process Development• Responsible to provide Product Development data to Regulatory affairs department for submission in respective Ministry (both local and Export)• Responsible for Manufacturing and Documentation of Lab Scale batches and Pilot Scale Batches• Responsible to involve during Process Validation of New Products

United Kingdom

Karachi

• Desktop survey for New Generic Drug Products and search for the Innovator drug• Literature study regarding the development of New Generic Drug product like FDA approvals, emc, MHRA,TGA, CMC data, PARs etc.• Development of New Generic Drug Product• Responsible for Formulation Development & Manufacturing Process Development• Responsible to provide Product Development data to Regulatory affairs department for submission in respective Ministry (both local and Export)• Responsible for Manufacturing and Documentation of Lab Scale batches and Pilot Scale Batches• Responsible to involve during Process Validation of New Products

Karachi

• Desktop survey for New Generic Drug Products and search for the Innovator drug• Literature study regarding the development of New Generic Drug product. Literature includes sites like FDA, emc, MHRA,TGA,Daily Med,CMC data, Public Assessment Reports etc.• Documentation of TBRs & MBRs• Preparation of BOM & ICOF for Item code opening• Maintaining log sheets and log books for all equipment in product development lab• Development of New Generic Drug Product• Responsible to provide Product Development data to Regulatory affairs department for submission in respective Ministry (both local and Export)• Responsible for Manufacturing and Documentation of Lab Scale batches and Pilot Scale Batches• Responsible to involve during Process Validation of New Products

Karāchi, Sindh, Pakistan

• Supervise Manufacturing processes in Tablet manufacturing area, Syrup Manufacturing area• Maintaining log sheets and log books in Production area of different processes• In-Process Tests during compression stage of Tablet manufacturing• Check Manufacturing area thoroughly before Line clearance• Filling of BMRs during manufacturing of Granules, Tablet and film coating.• Escalated concerns to management and helped develop and implement effective solutions.• Observed production work and made corrective actions to optimize performance.• Evaluated incoming materials and finished products against standards.• Wrote standard operating procedures and adjusted policies to meet changing demands.• Organized repair and routine maintenance of production equipment.• Recommended process improvements to enhance product quality.

Karāchi, Sindh, Pakistan

I have worked in their Out Patient & In Patient dispensing Pharmacies during my Academic year.We used to make Total Parenteral Nutrition's bags for oncology patients.Patients counselling, compounding and prescription handling was the major tasks during the 4 weeks duration of Internship.

Pharm-D, Pharmaceutical Sciences, 3.328 Cgpa

Intermediate, Pre-Medicine/Pre-Medical Studies, A+

Matriculation, Biology/Biological Sciences, General, A+

Got 12th Position in Karachi board with 92.7% marks