Manager Regulatory Affairs & International Business - PALPEX Pharmaceuticals Pvt.Ltd - Karachi
(2021-10)
- Preparation and execution of documents for all regulatory matters of the company.
- All related work for Contract manufacturing Business development.
- Preparation of export dossiers and all related work for business development in different countries.
- Take ownership and additional responsibilities in solving day to day problems.
- Follow up for all technical data required by importing country for product approval and other internal matters.
Assistant Manager Regulatory Affairs & International Business - Nexus Pharmaceuticals Pvt.Ltd - Karachi
(2017-01 - 2021-09)
- Preparation and execution of documents for all regulatory matters for international Business.
- Search for new drug molecules for new product developments.
- Review new art work which is use for product that will be export to different countries.
- Responsible for all shipment documents preparation and dealing with courier and Logistic companies.
- Preparation of NOC and all legalized documents required for exporting medicine to different countries.
- Dealing with agents in different countries for registration of medicines and full fill all documented requirement necessary for registration of medicines
- Take ownership and additional responsibilities in solving day to day problems.
- Follow up for all technical data required by importing country for product approval and other internal matters.
- Responsible for preparation of Invoices and Packing lists for final dispatch of medicines to port.
- Solving all technical quires related to finished product after shipment
Sr. Executive Regulatory Affairs & Quality control - Nexus Pharmaceuticals Pvt.Ltd - Karachi
(2016-01 - 2017-12)
- Preparation and execution of documents for all regulatory matters for Local & international Regulatory matters.
- Preparation of Dossiers CTD, ACTD, & Local Files for registration of new products for different countries and for local registration.
- Performing process & Analytical method validation and preparation of all related reports.
- Development of Analytical methods for new products.
- Coordinate with Vendors/ contractors for maintenance and purchasing of Lab. Equipments.
- Analysis of injections, Capsules, Tablets, creams, ointments, Water for Injections.
- Coordinate in Troubleshooting of Lab. Equipments.
- Preparation of analytical reports, standard operating procedure (SOP) and raw material monograph.
- Performing Analytical procedure for Finished and Raw material testing.
Analyst Quality Control - HEALTHTEK Pharmaceuticals Pvt.Ltd - Karachi
(2014-08 - 2015-10)
- Performing Analytical procedure for Finished and Raw material testing.
- Standard testing methods preparation for finished products and Raw materials.
- Analysis of injections, Capsules, Tablets, creams, ointments, Water for Injections using HPLC & other Instruments.
Executive Quality control - NOA HEMIS Pharmaceuticals Pvt.Ltd - Karachi
(2011-02 - 2014-05)
- Performing Analytical procedure for Finished and Raw material testing.
- Standard testing method preparation for raw materials.
- Review art work for approval.
- Responsible for Technical data submission for regulatory purpose.
Officer Quality Control & Quality Assurance - LINZ Pharmaceuticals Pvt.Ltd - Karachi
(2008-12 - 2011-01)
- Testing of finished pharmaceutical products.
- Preparation of certificate of Analysis for Finished products
- Inspection of products during manufacturing.
- Preparation of SOP for instruments like PH meter, conductivity meter, Melting point apparatus & spectrophotometer etc.
Management Trainee - BOSCH Pharmaceuticals Pvt.Ltd - Karachi
(2008-11 - 2008-12)
