Quality Assurance Medical Device
Resume:
Nazia Lakhani
Email Id: *********@*****.***
EDUCAT ION
Northeastern University
J une 2012
Boston, MA, USA
D egree: M asters of Science (M.S.) in Regulatory Affairs for Drugs, Biologics & Medical Devices
GPA- 3.5
R elated Coursework:
I ntroduction to Drug and Medical Device Regulation, New Drug Development Biologics Development, Medical Device
Development, Practical Aspects of Regulatory Affairs, Human Experimentation: Methodological Issues Fundamental to
C linical Trials, Managing International Clinical Trials, Food Drug and Medical Device Law
Mumbai education T rust
J une 2009
M umbai, I ndia
D egree: Bachelors in Pharmacy
GPA- 3.6
R elated Coursework : Forensic Pharmacy and Drug Regulation, Hospital Pharmacy, Pharmaceutical Management,
Pharmaceutics and Drug Delivery, Bio-pharmaceutics, Pharmacology- Pharmacology, toxicology, Pharmacokinetics and
Pharmacodynamics, Medicinal Chemistry, Pharmaceutical Analysis, Biotechnology
Affiliates:
• Life member of Regulatory Affairs Professional Society (RAPS)
• Cell member of Indian Pharmaceutical Association
WORK EXPER IENCE
AbbVie Inc. (Formerly Abbott Laboratories)
J uly 2012- Present
Chicago, I L
Position: Global Regulatory Affairs Associate
• Prepared and complied RA- HCV- Clinical Trial Application Dossier for two medicinal products for Regulatory
submission in China, Korea and Taiwan.
• Compiling appropriate Quality Assurance and Quality Control documents from QMS for variation submissions
i ncluding name change and fresh product registrations.
• Dossier compilation for label enhancements/ shelf life extension/ site name change submissions in Asia Pacific,
A ustralia and New Zealand
• Request CPP, GMP, Certificates of Manufacture and Free Sale and Certificates of Exportability from the
appropriate government including the USA FDA, Canada and EMA.
• Worked with requirements of Asia Pacific, Australia and New Zealand to have Marketing Authorization
T ransfers.
• Coordinating with the product managers to understand their product and its status in different countries.
• Communicate regulatory timelines with the supply chain and labeling group
• Drafting cover letters, declaration letters, Letter of Authorization and Power of Attorney for name change
variation submissions.
• Maintaining SOP’s for International Product Registrations.
• Communicated and coordinated with global affiliates in Asia Pacific, Australia and New Zealand to understand
t heir local regulatory authority requirements to make a regulatory filing for name change of the manufacturing
sites.
• Performed a qualitative assessment of the ICH CTD and the SA CTD Module 3- Quality, to produce comparative
study results
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Nazia Lakhani
Email Id: *********@*****.***
• Drafted a work plan for the RAPPG name change activity for Abbott in regions like Asia Pacific, Australia and
New Zealand
Cognizant Technology Solutions
D ec 2009 -July 2010
M umbai, I ndia
Position: Clinical Database Programmer
C lient: Novartis
• Authorized end users to access Clinical Trial Data, Studies and Clinical Report Forms, Pharmacovigilance Data
a t various security levels depending on the user profile and designation
• Ran SQL/PL SQL scripts to manage clinical studies and give clinical data access to Novartis scientists within
t argeted timelines
• Provided support for electronic Clinical Data Management software to Doctors, Scientists, Researchers, Lab
Technicians
• Documentation of work flow operations & formed report on daily basis for current and future activities using
M icrosoft office- Word and Excel
• Applications Supported: OC – RDC (Oracle Clinical – Remote Data Capture), ClinTrial, ClinAdmin CREDI,
REDI, PREDI, TEDI, TMS and DMS
• Setting up of WebEx meetings, preparing meeting agenda and taking down meeting minutes
• Worked with IBM Lotus Notes
Pharma Medico
J une 2008 - July 2008
M umbai, I ndia
Position: Q uality control and Quality Assurance Intern
• Worked in Analytical Department with Lidocaine, Anesthetic Gel as drug candidate
• Conducted Quality control tests on raw material and finished products
• Operated instruments like HPLC, UV Spectrophotometer, Granulators, Mixers and tube filing and crimping
machines
• Performed validation checks on distilled water equipment for accuracy and precision
• Executed line clearance tasks in packaging and labeling department
• Prepared Batch Manufacturing Records and assisted in reviewing Standard Operating Procedures
• Assisted with sampling, warehousing, dispensing and assigning E- codes to raw materials used in formulation
• Worked with compilation and quality control of documents including scanning, importing, bookmarking and
hyper linking
ACADE M IC PROJECTS
• Fictional PMA: P repared a regulatory plan for execution, in order to bring a Class I I I device for long bone
f racture in to market and also worked on submission special 510(k ) in order to extend its indications of use
February 2011
• Regulatory Development Plan : Presented a paper on combination product containing Intravenous device,
antibody monoclonal and an anti- inflammatory drug for the treatment of advanced stage of lung cancer
J une 2011
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Nazia Lakhani
Email Id: *********@*****.***
• Manufacturing Exercise: Participated in manufacturing exercise of a drug product in simulated GMP
environment and Drafted a BMR and Testing protocol using tech transfer procedure. Exercised change control
and QMS procedures M ay 2011
• D rafted Informed Consent : Actualized an informed consent document as per 21 CFR 50.25(a) and 21CFR
50.25(b) M arch 2011
• Development and Execution: Regulatory plans for the generation of recombinant DNA production documents
to regulatory agencies
M a rch 2011
• Fictional I N D : Created IND and NDA submissions for the drug Trilipix, for lowering blood cholesterol, to
simulate the actual regulatory submissions.
October 2010
• Poster Presentation : Presented a poster on Targeted Drug Delivery to the Brain at I ndian Pharmaceutical
Associations SF-MSB Technical Symposium 2009
February 2009
• Oral Presentation : Delivered an oral presentation on Dr. Reddy’s Polypills at I ndian Pharmaceutical
Associations SF-MSB Technical Symposium 2009
February 2009
S KILLS
R egulatory Affairs skills
• F iling I N D, NDA, ANDA and BLA, 510(k), PMA and I DE applications including their review and approval
p rocesses
• Regulations governing International Clinical Trials and IRB review; GMP’s, GLP’s and GCP’s; ISO13485,
quality, clinical and regulatory documents like BMRs, Product Deviation Forms, Annual Reports, IND Safety
Reports, Forms 1571 & 356(h), CSRs, Clinical Protocols, IC forms etc.
• FDA Regulations & ICH Guidelines; Strategic Planning and Project Management for Regulatory
Submissions and Approvals; Drug and Device Labeling; Pharmaceutical Advertising and Promotion; Regulation
of Combination Products, Generic Drugs and Biosimilars.
• eCTD; Pharmacovigilance; Adverse Event Reporting System (AERS); Post Marketing Surveillance; REMS;
P roduct Recalls.
• I nternational regulatory submissions, review and approval processes across USA, EU (EMA), Japan (PMDA),
China (SFDA), Latin America (ANVISA and ANMAT) and other emerging markets like Canada, India etc.;
M arketing Authorizations (MAs); Design Dossiers; Technical Files etc.
Computer Skills
• Knowledge of MS Word, MS Excel Spreadsheet, MS PowerPoint, MS Adobe Acrobat, Microsoft Outlook.
Available: W ithin 2 weeks of selection.
Visa Status- H1- B
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