Nazia Lakhani

Email Id: acc7iz@r.postjobfree.com

617-***-****

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: acc7iz@r.postjobfree.com

617-***-****

• 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

2

Nazia Lakhani

Email Id: acc7iz@r.postjobfree.com

617-***-****

• 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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