Aastha Kohli, M S, RAC (US, EU)

*** ****. ***, #* ******, MA 02115 Phone: 617-***-**** E-Mail:

abobwa@r.postjobfree.com

H ighly self-motivated RA /QA professional with inherent goal-oriented and multi-tasking

skil ls.

G reat eye for detail along with proven organizational, analytical, leadership and

communication skills.

P ROFESSIONAL EXPER I E NCE

Regulatory Affai rs Special ist (contractor), H aemonetics Corporation, MA

J ul 2012-Dec 2012

• Provided support in review and submission of:

- 510(k) (traditional and special) (STED format);

- EU technical files and design dossiers;

- Pre-IDE meeting and IDE request

• Supported Haemonetics acquisition of Pall Corporation:

- US and OUS device registrations and listings;

- Reviewed labels and IFUs for global regulatory compliance;

- Applied for CFGs/COEs/CFSs, and apostille/legalization;

- Submitted Health Canada device (MDL) and establishment licenses (MDEL);

- Worked with global cross-functional teams

• Assisted in preparation for EU Notified Body Inspection

• Worked on CAPAs and recalls

Regulatory Affai rs/Quality Assurance Co-op, Acceleron Pharma, MA

J an 2012-Jun 2012

• Supported quality systems compliance with F DA and EU regulations and ICH

guidelines

• Assisted document control, r isk management, gap analysis, optimization of quality

systems

• Lead the electronic Change Control Management project and created:

- Process mapping

- User Requirement Specifications (URS) and Functional Requirement

Specifications (FRS)

- Installation Qualification (IQ) and Performance Qualification (PQ)

- Risk Assessment, Validation Master Plan (VMP), SOP and conducted t raining

• Assisted the management of change controls, deviation, OOS, NCMRs and CAPA

• Reviewed stability data and batch records

• Assisted supplier quality management

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• Supported internal GMP and GLP audits; audit scheduling

• Assisted in reviewing regulatory submission documents for CMC module

Regulatory Affai rs/Quality Assurance I ntern, D r. Reddy’s Laboratories,NJ

J un 2011-Dec 2011

• Supported project management and regulatory strategy group

• Researched and analyzed regulatory requirements to provide updated regulatory

i nformation

• Compiled, reviewed and made regulatory submissions (eCTD format) including

I ND/NDA/ANDA, annual reports and amendments (including information, protocol and

C MC amendments)

• Participated in external GCP and GMP audits and prepared audit reports

• Helped in setting up of quality system

• Assisted in wri ting clinical protocols, reviewing nonclinical and clinical study

reports and maintaining TMF

• Drafted regulatory strategy for using social media in DTCA

• Assisted Pharmacovigilance submissions: PSUR, spontaneous ADEs and 15-Day

a lert reports

• Helped in regulatory operations like OPDP submissions, Structured Product

L abeling (SPL) and drug listing

C linical Pha rm acy Pr actice I ntern, H CG Medisurge Hospitals, India

J an 2010-Jun 2010

• Patient counseling, dispensing, audits, adverse events and medication errors

reporting & documentation

Q uality Assurance Associate in Production Department, Merril Pharma Pvt. L td.,

I ndia Nov 2008–Aug 2009

• Provided Quality Control(QC) support in manufacturing operations of drugs

p roducts

• Assisted in document control-preparation and archiving of SOPs, batch

manufacturing records (BMR), and internal audit reports

A astha Kohli, M S, RAC (US, EU)

395 Mass. Ave, #4 Boston, MA 02115 Phone: 617-***-**** E-Mail:

abobwa@r.postjobfree.com

ED UCAT ION

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M .S. Regulatory Affai rs for D rugs, Biologics and Medical Devices, Northeastern

U niversity, USA J un 2012

GPA: 3.7/4.0

B achelor of Pharmacy Honors, N i rma University, Institute of Pharmacy, India

J ul 2010

GPA: 4.0/4.0

B achelor of Pharmacy, Rajiv Gandhi University, India

Oct 2008

T hesis: Estimation of Hypoglycemic Activity in STZ induced Diabetic Rats via SD and MD

s tudies

GPA: 4.0/4.0

CERT I F ICAT IONS

Regulatory Affairs Certification (RAC) – US and EU

P UBL ICAT IONS

Aastha Kohli & Shrenik Desai. How Do You Define Regulatory Compliance? Regulatory Focus,

J uly ‘11; 16(7):36-42

A astha Kohli & Shrenik Desai. Nanomedicine: Current Regulatory Scenario and Prophylactic

Regulatory Strategies. Regulatory Focus, January ’12; 1-7

K NOWLEDGE AND SK I L LS

R egulatory Affai rs:

• I ND, NDA, ANDA, BLA, IDE, PMA & 510(k) submissions with 21 CFR part 807,

312, 314 & ICH guidelines

• Clinical : GCP and GLP regulations

• Quality : GMP regulations including 21 CFR part 210, 211, 820, ISO 13485:2003,

I SO 14971

• Global device regulations including USA, Europe, Canada, Asia-Pacific and Latin

A merica

Computer Systems:

• Proficient in Microsoft Office, SharePoint, Visio, Agile, Oracle, Adobe, Lotus Notes,

M aster Control, QUMAS, Tarius, Cit r ix Docubridge and Labelbridge.

H ONORS AND ACH I EVE M E N TS

• Best Graduate Student Award 2012, Northeastern University, USA

• International Student Dean’s Scholarship (Top 5%), Northeastern University, USA

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• Recipient of Gold Medal for Academic Excellence (2005-08); Recipient of Best Student

Award (2004-08); Recipient of University Ranks, (2005-08) (Top 3%), Rajiv Gandhi University of

Health Sciences, India

L EADERSH I P ROLES

Event Organization Support, RAPS NY/NJ and Boston Chapter, Medical

Development Group (MDG) meetings

Or ientation Leader, I n ternational Student and Scholar Institu te (ISSI), Northeastern

U niversity

Event Organization Volunteer, South Asian (Bone) Mar row Association of Recruiters

(SAMAR)

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