Muhammad Asim
Regulatory Affairs & BD Pharmacist
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About
Aspiring to contribute towards growth in a highly competitive and adaptable learning
Organization to build up my skills through constant challenges and bring an imperative change in the field.
Experience
Regulatory Affairs Pharmacist
Wilson’s Pharmaceuticals (Pvt) Ltd
Senior Officer Regulatory Affairs (& Business Development)
Focus & Rulz
I Pharmaceuticals (Pvt) Ltd I Healthcare (Pvt) Ltd I Consumer Division
Experience
o Concern with all Regulatory Affairs, BD documentation, Import / Export and DRAP visit.
o Healthcare product Enlistment (Local, Export & contract Manufacturing)
o Pharmaceuticals Product Registration & Renewals (Local, Export, Import & Contract
Manufacturing).
o Consumer Division products Registration with Pakistan Standard Quality Control
Authority – PSQCA.
o Concern with Registration & documentation with DRAP, Ministry of Narcotics -ANF,
IPO – for Trademark Registration.
o Hands on Online Software’s, DRIS, PRIMIS, IPO, Import/Export Online Fee Generation and DHL o Concern with Inspections & audits, DRAP, Exporting countries, ISO, ANF & PSQCA.
Regulatory Affairs Officer
Bio-Labs Pharmaceuticals (Pvt) Ltd, Islamabad
Experience
o Concern with regulatory documents including Technical Files, product registration,
Renewals, Price increase (CPI, SRO’s) Update Product list (Local, Export, Veterinary & Toll manufacturing), deficiencies and regulatory documentations.
o Communications (written, Tele and direct) with regulatory agencies/ DRAP.
o Form- 5 dossiers (Local & Export) Human Section and veterinary section.
o Common Technical Dossiers –CTD and ACTD.
o Working on Drug Regulatory Information Management System (DRIM-S) site.
o Assisted in the development and maintenance of regulatory files, records and reporting systems.
o Concern with DTL (Drug Testing Labs) and Drug Inspector / FID letters.
o Export / Import NOC, COPP, COO, Dossiers, Agreements, and other documentation.
Education
Pharm-D (Doctor of Pharmacy)
University of the Poonch,
Rawalakot, Azad Jammu Kashmir
F.Sc (Pre-Medical)
ANSI Degree College,
BISE-Mardan KPK
S.S.C Science Group
SEENA Public School, Katlang
BISE-Mardan KPK
