1. ASIM MIRZA
D-138, Block 4,
Federal ‘B’ Area, Karachi-75950
Ph. No.: 021-36349633
Cell No. 03002174687
E-mail: asim_mirza@hotmail.com
CAREER OBJECTIVE:
To obtain a challenging position in the areas of Regulatory Affairs,
Quality Assurance/ Quality Control, Manufacturing, Research and
Development of Pharmaceuticals and Clinical Research.
EDUCATION:
1999 Master of Science in Biotechnology.
Griffith University,
School of Biomedical and Biomolecular Sciences,
Brisbane, Australia.
Key subjects:
Molecular Genetics, Management and Regulatory Affairs
(Including cGMP), Clinical Laboratory and Analytical Techniques,
Biotechnology processing (Including Expression systems,
Designing of vectors, Vaccine development, Bioinformatics),
DNA Technology, Biotechnology Laboratory (Including
Fermentation Technology), Advanced Plant Biotechnology.
Research:
Conducted research as the part of the M.Sc. Thesis on the effects
of Noxious Stimulation on FosB Transcription Factor in Thalamus
and Hippocampus. The title of my Thesis was:
“FosB Transcription Factor in the Thalamus and Hippocampus
after Noxious Stimulation”.
Publication:
Pearse D, Mirza A, Leah J. (2001). Jun, Fos and Krox in the
hippocampus after noxious stimulation: simultaneous-input-
dependent expression and nuclear speckling. Brain Res.
894(2):193-208.
1996 Bachelor of Pharmacy.
Faculty of Pharmacy
University of Karachi, Karachi.

2. Key subjects:
Biochemistry, Physiology, Microbiology (Including
Pharmaceutical Microbiology, Fermentation, Bacteriology),
Mathematics, Statistics, Management, Economics, Pharmaceutical
Chemistry (Including Physical, Organic and Medicinal Chemistry),
Pharmaceutics, (including Industrial Pharmacy, Hospital
Pharmacy, Bio Pharmaceutics, Pharmacokinetics), Pharmacology,
Pharmacognosy.
1991 Higher Secondary Certificate.
St. Patrick’s Govt. College, Karachi.
1988 Secondary School Certificate.
St. Andrew’s High School, Karachi.
PROFESSIONAL TRAININGS:
1997 Certificate of Industrial Pharmacy.
GlaxoWellcome Pakistan Ltd., Karachi, Pakistan.
1997 Certificate of hospital Pharmacy.
Karachi Adventist Hospital, Karachi, Pakistan.
1997 Participation in one day seminar on Herbs, Medicines and
Therapeutics organized by Pakistan Society of Pharmacognosy,
Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
EMPLOYMENT:
2016-Till Date Manager Regulatory Affairs,
Nabiqasim Industries (Pvt.) Ltd., Karachi.
Responsibilities:
• Managing registration including new registrations and
renewals of registered products for different countries
(ASEAN, AFRICAN, CIS and SOUTH AMERICAN
countries).
• Managing data like guidelines of different countries for
registration purpose and handling matters related to
interdepartmental management of ACTD and CTD formats.

3. • Development of product leaflets, clinical data, medical
literature and providing Clinical Assistance.
• Liaison with Research and Development, Quality Control,
Quality Assurance and Production, Business development
and Import departments along with Regulatory team
regarding registration / renewals matters like
documentation, packaging and samples etc
• Liaison with Graphic department for art work preparation
according to guidelines and formats of specific country.
• Managing all Regulatory Affairs activities in coordination
with all team members of Regulatory Affairs and
International Marketing departments.
• Coordinate and monitor all matters related to registration /
renewal where necessary with regulatory authorities via
agent, in different export countries.
2015-2016 Manager Regulatory Affairs (International Division),
Hilton Pharma (Pvt.) Ltd., Karachi.
Responsibilities:
• New registrations and renewals of registered products for
different countries (ASEAN, AFRICAN and CIS
countries).
• Managing data like guidelines of different countries for
registration purpose and handling matters related to ACTD,
CTD, DMF, Clinical data (including, Neutraceuticals and
Veterinary Products).
• Development of leaflets.
• Liaison with Product Development Department regarding
registration / renewals matters like documentation,
packaging and samples etc.
• Liaison with Creative Department for art work preparation
according to guidelines and formats of specific country.
• Coordinate and monitor all matters related to registration /
renewal with regulatory authorities via agent, in different
export countries.
• Record keeping of new registrations / renewals approvals.
• Coordinate & documentation for cGMP inspection.
2014-2015 Assistant Manager Regulatory Affairs,
Nabiqasim Industries (Pvt.) Ltd., Karachi.
Responsibilities:
• Preparation of Registration Dossiers and related
documentation required for registration of Drugs for other
countries.
• Working with ACTD, CTD and country specific formats.

4. • Generating products leaflets, medical literature and
providing Clinical Assistance.
• Managing International Registration work.
2011-12 Assistant Manager Regulatory Affairs,
OBS Pakistan (Pvt.) Ltd., Karachi.
Responsibilities:
• Registration Dossiers preparation and related
documentation required for registration of Drugs in
Pakistan, for other countries and for imported drugs.
• Working with ACTD, MHRA/ICH-CTD formats, dealing
with price fixation / hardship cases.
• Correspondence with MOH, filing upcoming variations for
imported products.
• Development of artworks of MSD products through online
system AMS blue.
• Development of products leaflets.
2005-11 Assistant Manager Regulatory Affairs,
Nabiqasim Industries (Pvt.) Ltd., Karachi.
Responsibilities:
• Preparation of Registration Dossiers and related
documentation required for registration of Drugs in
Pakistan, for other countries and for imported drugs.
• Working with ACTD and CTD formats, Generating
products leaflets, medical literature and providing Clinical
• Assistance. Managing International Registration work.
Internal ISO / cGMP Auditor.
2002-5 Regulatory Affairs Officer,
Indus Pharma (Pvt.) Ltd., Karachi.
Responsibilities:
• Preparing Registration Dossiers and related documentation
required for registration of Drugs in Pakistan and for other
countries.
• Identification of New Molecules, Formulation development
of New Drugs, cGMP rounds and QA Documentation.

5. 2001-2 Manager Clinical Research,
Clinical Research Department,
Sequoia Pakistan Pvt. Ltd. (Formerly Samtech Research Inc.),
Karachi.
Responsibilities:
Conducted research on various Diseases, Herbs, Vitamins,
Minerals and Supplements, responsibilities include reviewing of
literature, providing Clinical Assistance and Advisory, managing
and updating Clinical Data base.
2000-1 Research Associate,
Orthopedics Research lab,
Aga Khan University Hospital, Karachi.
Responsibilities:
Investigating the role of nervous system in bone healing and in the
pathophysiology of a variety of bone and joint diseases, with
immunohistochemistry as the main research methodology.
2000 Quality Assurance Officer (Auditing and Inspection).
Abbott Laboratories (Pakistan) Ltd., Karachi.
Responsibilities:
Auditing of Manufacturing and Dispensing Areas/ Procedures,
Quality Control Labs. (Including Instrumental, Chemical and
Bacteriological Labs.), Warehouse, cGMP rounds, In-process fill
checks, Auditing of Batch Documents and QA Documentation.
COMPUTER SKILLS:
• Working knowledge in MS-Windows 2000, XP, MS-Office.
• AS-400.
EXTRACURRICULAR ACTIVITIES:
Executive Member, Horizon Magazine Committee (1995), Faculty
of Pharmacy, University of Karachi, Playing Chess, Reading
Books.

6. ACCREDITATIONS:
• Registered Pharmacist with Sindh Pharmacy Council, Karachi..
• Member of Griffith University Alumni Association, Brisbane,
Australia.
• Member of University of Karachi, Pharmacy Alumni.
PERSONAL DATA:
Father’s Name : Dr. Ikhtiyar Hussain Mirza
Date & Place of Birth : 24th
August 1971, Karachi.
N.I.C. No. : 42101-1772967-7
Marital Status : Married
Nationality : Pakistani
REFERENCES:
Available upon request.

7. ACCREDITATIONS:
• Registered Pharmacist with Sindh Pharmacy Council, Karachi..
• Member of Griffith University Alumni Association, Brisbane,
Australia.
• Member of University of Karachi, Pharmacy Alumni.
PERSONAL DATA:
Father’s Name : Dr. Ikhtiyar Hussain Mirza
Date & Place of Birth : 24th
August 1971, Karachi.
N.I.C. No. : 42101-1772967-7
Marital Status : Married
Nationality : Pakistani
REFERENCES:
Available upon request.