*Updated on: 31-12-2017 11 Years

WAQAS ALI KHAN Page 1 of

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PHARMA REGULATORY AFFAIRS / QUALITY OPERATIONS PROFESSIONAL

CURRENT POSITION: MANAGER REGULATORY AFFAIRS [ZAFA PHARMACEUTICAL)]

Professional Eleven & Half Years Career Experience Academic Experience (Teaching / Student
[Pharmaceutical – National and Multinational Companies Counseling) 15 Years -Academic Qualification:
(BIMSLINK, PFIZER, INDUS PHARMA, ROYAL GROUP, Master in Political Sciences – Double Master in
ZAFA PHARMA)] Professional Qualification: B.Sc – Certificate International Relations – Certificate course on
course on Medical Transcription - MBA (Health Management) - Journalism -Certificate course on News Reporting
MS (Management Sciences) -

Home Address: B-6, Abdullah

waqasskhan@gmail
wxid_yqck352iah5q2 .com Cell # +92333-2372813 Terrace, Block-16, Gulistan-e-
/ (We Chat) +92300-2969141 Juhar, Karachi-74900, Pakistan

➢PROFESSIONAL PROFILE: A RegulatoryAffairs/ Quality Operations Professional with eleven years drug development experience, which
within global regulatory affairs. Broad experience across various therapeutic areas. Proven scientific, regulatory and managerial expertise in
driving both early development teams and full development programs (overseeing the preparation of CTD, ACTD, NDA and specific dossier
format, successfully submission, cGMP inspection / general inspection as per requirement of global health authorities / manufacturing
requirements).A proven ability to lead and manage quality teams through complex global regulatory submissions and interactions with
numerous global health authorities (including DRAP, TFDA, NDA, EFMHACA, ZMRA, MINISANTE, NMRA, PPB, MRA, PBS,
LMHRA,WHO and other regional country authorities).Ability to could be adjusted in highly professional demanding fields like Human
Resources Management, Administration and Top Management Level – Strategic and Planning Division.

CORE RESPONSIBILITIES
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REGULATORY AFFAIRS QUALITY OPERATIONS
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Organize, developing and delivering the regulatory strategy ✓ QA Department: General Inspection/sampling/testing/batch record
for achieving a favorable outcome. documentation of dosage forms according to Quality Standard
✓ Export Regulatory issues. Procedure. Vendor’s Audit as per Audit plan.

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✓ National Regulatory issues. ✓ QO Department: Sampling & Testing the Product(s) as per PQS

✓ New products registration. (Pfizer Quality Standard). Approved / rejected the consignment(s) as

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Other countries product registration and queries. per Pfizer Specification.

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✓ Health & OTC, Alternative Medicines and Medical the Patient Diseases / Treatment and prepared the patient’s history up

✓ Design control issues (new, existing and as per requirement Proofreading of new or improved packaging materials artwork such as
of Importing countries). printed boxes, leaflets, labels and other relevant literatures of the drugs
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Institutional / GovernmentalRegistration and related Issues. ✓ As Medical Transcriptionist: Transcribe the Doctors’ Lecture about

OF
Devices registration and related queries. to current status.
KEY SKILLS AND COMPETENCIES
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Participate in WHO, UNICEF and global health authorities’ ✓ In Administrating Department :Routine Administrative Matters-
tenders. Including documentation, inventory build-up & stocking, staffing &
organizing also Collecting and up-dating Patient’s Data on daily basis .

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MANAGERIAL ABILITIES PERSONAL QUALITIES
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✓ Sense of Objective and Direction. ✓ Honesty.

✓ Communication and Interpersonal Skills. ✓ Technical Competency.
✓ Emotional Intelligence. ✓ Work Ethic.
✓ Decision Making and Problems Solving Abilities. ✓ Flexibility.
✓ Leadership Skills. ✓ Determination and Persistence.
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✓ Motivational Incentives. Ability to work in Harmony with Co-Workers.
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➢ ✓ Eager and willing to add more knowledge.
POSITION / RECOGNITION / TRAINING
PROFESSIONALRisk-Taking.
✓ Loyalty.

✓ TranspManarencygerRegulatory. Affairs 2018 - Present – ZAFA Pharmaceutical, Karachi Pakistan

✓
➢ Manager Regulatory Affairs and R & D 2015 - 2018 - Royal Group, Karachi Pakistan
SPECIALTIES: Different thinking, Concept proposals, Creative Ideas & Ability to try and implement something new, Eager to improve
performance✓Assist anteveryManaglevel,r RegulatoryEffectivelymeetAffairsupchallenging2014–2015situations,-INDUSTimePHARMAmanagement,(Pvt)LtdAble.Karatocommunichi,Pakistaten diverse group of people, Creative
Skills (Anchoring, Speaking, Discussion, Poetry writing etc.)
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Senior Officer Regulatory Compliance 2012 – 2014 - INDUS PHARMA (Pvt) Ltd. Karachi, Pakistan
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Experienced in Microsoft Office (Excel, Access, and Word & PowerPoint Presentation), Experienced in Pharmaceutical Industrial Software; ✓ Officer Regulatory Compliance 2010 – 2012 - INDUS PHARMA (Pvt) Ltd. Karachi, Pakistan

MAPS and Spectrum (Analytical Program), Excellent Language Skills (Urdu & English), Progressive Interpersonal Skills with Leadership &
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Organizational Officer QualitySpirit. Assurance 2006 – 2008 - INDUS PHARMA (Pvt) Ltd. Karachi,Pakistan
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Quality Control Analyst – Packaging Material Section 2004 - 2006
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PFIZER LABORATORIES (PARKE-DAVIS & COMPANY LTD) Karachi, Pakistan
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Medical Transcriptionist 2003 – 2004
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BIMSLINK INFORMATION & TECHNOLOGY, Karachi, Pakistan
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APPRECIATION LETTER
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(Received From Director Plant Operations – Indus Pharma (Pvt.) Ltd – February 24 2015)
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CERTIFICATE OF APPRECIATION
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(In Recognition of Participation in Safety and cGMP Week from 7 April to 11 April 2014 at Indus Pharma (Pvt,) Ltd., Karachi,
Pakistan)
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“Good Manufacturing Practices and Dossiers Assessment (PQP) as per WHO Guide Lines”(Participated in 02 days Workshop
th th
from 08 October to 9 October 2013 at Marriot Hotel, Islamabad, Pakistan)
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PROFESSIONAL / ACADEMIC EDUCATION
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Mohammad Ali Jinnah University : MS (Management Sciences) - In progress
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University of Karachi : Double MA in International Relations – 2014
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Preston University, Karachi-Pakistan:MBA (executive) in Health Management, 3.1 Grade Point Average – 2010
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News Reporting: Skills & Proficiency Certificate - Islamabad Academy, Pakistan – 2006
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University of Karachi:MA in Political Science – 2005

“QUALITY OF LIFE IS A MEASUREMENT OF KNOWLEDGE”

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Journalism:Skills Certificate & Proficiency - Islamabad Academy, Pakistan -2004
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Medical Transcription:Bimslink Information & Technology, Karachi, Pakistan – 2004
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Government Islamia Science College : B.Sc in Microbiology, Biochemistry, Zoology – 2003
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Government Islamia Science College, Karachi- Pakistan: Intermediate in Pre-medical Science – 2000
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Little Scholar High School, Karachi – Pakistan: Matriculation - Science Group – 1997
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PROFESSIONAL / ACADEMICCOLLOBRATION
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Healthcare and Social Welfare Association (HASWA) - Project: Artificial Limb Centre 2008 – 2010 - As Executive
Administrator Officer (Evening)
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Rotary Club International, Karachi - Gulistan-e-Juhar, Centre, Karachi-Pakistan - Teaching, as Computer Instructor for
MS Office – Advanced - (During Summer & Winter Vacations) 2008 – 2010
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ACADEMICACTIVITIES / RESEARCH & PROJECTS
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ARTICLES (Letters to the editor)
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Research Topics of MBA 2008 – 2009 - Projects:(a) Health Planning (b) Hospital Management (c) TQM (d) HRM for Health
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Create & Design Finished Good Transfer Note (FGTN) Build-in Software on Microsoft Excel for Indus-Pharma (Pvt) Ltd.
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Create & Design Patients Data Record Build-in Software on Microsoft Excel &Access for Healthcare and Social Welfare
Association (HASWA) Project: Artificial Limb Centre.
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PERSONAL INFORMATION:
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Father’s Name: Safdar Ali Khan Date of Birth: Wednesday, March 4, 1981 C.N.I.C # 42201-0489845-1 Passport # TR4108452
NTN # 3140360-3 Marital Status: Married (Children: 01) Religion: Islam Country: Pakistan City: Karachi
Nationality: Pakistani Languages: English and Urdu Abbreviation: WAK Short Name: Wiki
➢ REFERENCES & RECOMMENDATIONS
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Raja Rub Nawaz - Professor /Preston University