Waqas Ali Khan

Page 1 of 2 WAQAS ALI KHAN *Updated on:- Years PHARMA REGULATORY AFFAIRS / QUALITY OPERATIONS ATIONS PROFESSIONAL(PHARMACEUTICALS) PROFESSIONAL | RA FREELANCER & CONSULTANT CO CURRENT POSITION: SENIOR MANAGER REGULATORY AFFAIRS A [QATAR PHARMACEUTICAL INDUSTRIES] Professional 14.5 Years Career Experience [Pharmaceutical – National and Multinational Companies (BIMSLINK, PFIZER, INDUS DUS PHARMA, ROYAL GROUP, GR ZAFA GROUP (PHARMACEUTICAL (PHARMACEUTICAL), QATAR PHARMACEUTICAL INDUSTR RIES] Professional Qualification: B.Sc – Certificate course on Medical Transcription - MBA (Health Management) - MS (Management Sciences) https://www.linkedin.com/in /waqas-ali-khan-/ -- Academic Experience (Teaching / Student Counseling) 15 Years -Academic Academic Qualification: Master in Political Sciences – Double Master in International Relations – Certificate course on Journalism -Certificate Certificate course on News Reporting - Cell #-, - Home Address: B-6, B Abdullah Terrace, Block-16, Block Gulistan-eJuhar, Karachi-74900, Karachi Pakistan PROFESSIONAL PROFILE:: A RegulatoryAffairs/ Quality Operations Professional with 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 NDA, GCC and specific dossier format, successfully submission, cGMP inspection / general inspection as per requirement of global health authorities / manufacturing requirements).A requirements 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, LMHRA,CIS IS Countries, WHO and other regional country authorities).Ability Ability to could be adjusted in highly professional demanding fields like Human Resources Management, Administration and Top Management Level – Strategic and Planning Division Division. CORE RESPONSIBILITIES REGULATORY AFFAIRS QUALITY OPERATIONS QA Department: General Inspection/sampling/testing/batch record strategy for achieving a favorable outcome. documentation of dosage forms according to Quality Standard Export Regulatory issues. Procedure. Vendor’s Audit as per Audit plan. 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 Other countries product registration and queries. per Pfizer Specification. Design control issues (new, existing and as per Proofreading of new or improved packaging materials artwork such as requirement of Importing countries). printed boxes, leaflets, labels and other relevant litera literatures of the drugs Institutional / GovernmentalRegistration and related As Medical Transcriptionist: Transcribe the Doctors’ Lecture about Issues. the Patient Diseases / Treatment and prepared the patient’s history up Health & OTC, Alternative Medicines and Medical to current status. Devices registration and related queries. In Administrating Department :Routine Routine Administrative MattersMatters Participate in WHO, UNICEF and global health Including documentation, inventory build-up up & stocking, staffing & authorities’ tenders. organizing also Collecting and up-dating dating Patient’s Data on daily basis basis. KEY SKILLS AND COMPETENCIES MANAGERIAL ABILITIES PERSONAL QUALITIES 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. Motivational Incentives. Ability to work in Harmony with Co-Workers. Risk-Taking. Eager and willing to add more knowledge. Transparency. Loyalty. SPECIALTIES: Different thinking, Concept proposals, Creative Ideas & Ability to try and implement something new, Eager to improve performance at every level, Effectively meet up challenging situations, Time management, Able to communicate diverse group of people, Creative Skills (Anchoring, Speaking, Discussion, Poetry wri writing etc.) Experienced in Microsoft Office (Excel, Access, and Word & PowerPoint Presentation), Experienced in Pharmaceutical Industrial Software; MAPS and Spectrum (Analytical Program), Excellent Language Skills (Urdu & English), Progressive Interpersonal Skills with Leadership & Organizational Spirit. “QUALITY OF LIFE IS A MEASUREMENT OF KNOWLEDGE” Organize, developing and delivering the regulatory Page 2 of 2 PROFESSIONAL POSITION / RECOGNITION / TRAINING Sr. Manager Regulatory Affairs 2021- Present – Qatar Pharmaceutical Industries, Doha, Qatar Manager Regulatory Affairs 2018 - 2021–ZAFA ZAFA GROUP (Pharmaceutical), Karachi, Pakistan Manager Regulatory Affairs and R & D 2015 - 2018 - Royal Group, Karachi Pakistan Assistant Manager Regulatory Affairs 2014 – 2015 - INDUS PHARMA (Pvt) Ltd. Karachi, Pakistan Senior Officer Regulatory Compliance 2012 – 2014 - INDUS PHARMA (Pvt) Ltd. Karachi, Pakistan Officer Regulatory Compliance 2010 – 2012 - INDUS PHARMA (Pvt) Ltd. Karachi, Pakistan Officer Quality Assurance 2006 – 2008 - INDUS PHARMA (Pvt) Ltd. Karachi,Pakistan Quality Control Analyst – Packaging Material Section 2004 - 2006 PFIZER LABORATORIES (PARKE-DAVIS DAVIS & COMPANY LTD) Karachi, Pakistan Medical Transcriptionist 2003 – 2004 BIMSLINK INFORMATION & TECHNOLOGY, Karachi, Pakistan Drug Regulatory Authority of Pakistan (DRAP) & USP PQM [Attended session of "Establishment Licensing and New Inspection System” on 05th June, 2020] Drug Regulatory Authority of Pakistan (DRAP) [Attended Training of Drug-Integrated Integrated Regulatory Information Management System – (D-IRIMS) on 22nd July, 2019] “Good Manufacturing Practices and Dossiers Assessment (PQP) as per WHO Guide Lines”( Lines”(Participated Participated in 02 days Workshop from 08th October to 9th October 2013 at Marriot Hotel, Islamabad, Pakistan) \ APPRECIATION LETTER (Received From Director Plant Operations – Indus Pharma (Pvt.) Ltd – February 24th 2015) CERTIFICATE OF APPRECIATION (In Recognition of Participation in Safety and cGMP Week from 7th April to 11th April 2014 at Indus Pharma (Pvt,) Ltd., Karachi, Pakistan) Greenwich University : Master of Philosophy in International Relations & Politica Political Science – On-Hold Hold due to Pandemic University of Karachi : Double MA in International Relations – 2014 Preston University, Karachi-Pakistan:MBA MBA (executive) in Health Management, 3.1 Grade Point Average – 2010 News Reporting: Skills & Proficiency Certificate - Islamabad Academy, Pakistan – 2006 University of Karachi:MA MA in Political Science – 2005 Journalism:Skills Skills Certificate & Proficiency - Islamabad Academy, Pakistan -2004 Medical Transcription:Bimslink Bimslink Information & Technology, Karachi, Pakistan – 2004 Government Islamia Science College : B.Sc in Microbiology, Biochemistry, Zoology – 2003 Government Islamia Science College, Karachi Karachi- Pakistan: Intermediate in Pre-medical Science – 2000 Little Scholar High School, Karachi – Pakistan: Matriculation - Science Group – 1997 PROFESSIONAL / ACADEMICCOLLOBRATION COLLOBRATION Healthcare and Social Welfare Association (HASWA) - Project: Artificial Limb Centre 2008 – 2010 - As Executive Administrator Officer (Evening) Rotary Club International, Karachi - Gulistan-e-Juhar, Gulistan Centre, Karachi-Pakistan - Teaching, as Computer Instructor for MS Office – Advanced - (During Summer & Winter Vacations) 2008 – 2010 ACADEMICACTIVITIES / RESEARCH & PROJECTS ARTICLES (Letters to the editor) Research Topics of MBA 2008 – 2009 - Projects:(a) Projects:(a) Health Planning (b) Hospital Management (c) TQM (d) HRM for Health Create & Design Finished Good Transfer Note (FGTN) Build Build-in Software on Microsoft Excel for Indus-Pharma Pharma (Pvt) Ltd. Create & Design Patients Data Record Build Build-in Software on Microsoft Excel &Access cess for Healthcare and Social Welfare Association (HASWA) Project: Artificial Limb Centre. PERSONAL INFORMATION: Father’s Name: Safdar Ali Khan Date of Birth:: Wednesday, March 4, 1981 C.N.I.C #- Passport # TR- NTN #-Marital Status: Married (Children: 02)Religion: 0 Islam Country: Pakistan City: Karachi Nationality: Pakistani Languages: English and Urdu Abbreviation: WAKShort Name: Wiki REFERENCES & RECOMMENDATIONS Raja Rub Nawaz - Professor /Preston University Adeeb-ur-Rasool–Professor Professor / Preston University Saima Fahmi–Head/ Department of Biochemistry, Govt. Islamia Science College “QUALITY OF LIFE IS A MEASUREMENT OF KNOWLEDGE”- (13 YEARS) PROFESSIONAL / ACADEMIC EDUCATION