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概要
Experienced Regulatory Affairs Specialist with a demonstrated history of working in the pharmaceutical industry.
Well-versed with DRAP Guidelines, WHO Technical Report Series-970 Annex-4, ICH M4Q(R-3) & ICH Quality Guidelines for CTD/ACTD dossier writing.
Skilled in DRAP Dealings and Expert in the Following
1- Herbal and Neutraceuticals (Application for HOTC Establishment Form-6 & Enlistment Form-7 etc)
2- Medical Devices & Cosmetics (Application for Establishment License and Enlistment etc)
3- Product Renewals
4- Copp/FSC issuance
5- Pricing Matters (Hardship Case Application, Annual CPI Application, New Drug Entry Application)
6- ANF Groundcheck & Quota Allocation for Controlled Drug Substances and Pre-Cursor Chemicals
7- GMP Application
8- DML Application through PIRIMS
9- Create Replies for Drug Inspectors, Drug Testing Labs, PQCB, DQCB, DRAP etc.
10- Drug Sales License Application
11- PSQCA Registrations of Consumer Products etc.
项目
工作经历
Regulatory Affairs Specialist
I am responsible for expediting and supervising all Regulatory Submissions to local & export for Registration.Coordination between Business Development at the Head Office & Research &
Development/Product Development Department at the Factory to expedite the documentation for registration of products.Participation in Business Development to achieve Management Goals. To facilitate all local as well as international Regulatory Documentation approvals.Coordinate and facilitate Local DRAP audits as well as International delegation audits.To manage all necessary documentation required for achieving business targets through proper & effective liaison throughout Pakistan DRAP Offices, especially Lahore Field Office.
