PRACHI DALAL

th

**** * ** ******, ***.**, Los Angeles, CA-90007

Cell: 213-***-**** Email: acdp33@r.postjobfree.com

EDUCATIONAL BACKGROUND:

University of Southern California, Los Angeles, CA Expected Graduation: May 2014

Master of Science in Regulatory Science

Graduate Coursework:

- Regulation of Pharmaceutical and Biological Products - Regulation of Medical Devices and Diagnostics

- Introduction to Medical Product Regulation - Quality Systems and Standards

- Management of clinical trials - Clinical Trial Design and Statistic

- Medical Product Law - Chemical Manufacturing Controls

- Pre-clinical studies - International Approaches to Medical Product

- Biomedical Commerce Regulation

University of Mumbai, India Aug 2006 - May 2010

Bachelor of Pharmacy

SKILLS:

- 21 CFR § 50, 54, 56, 312, 314, 316, 801, 803, 807, 812, 814, 820, 821, 822 and ISO: 13485, 14971, 10993, 90001.

- FMEA, FTA, CAPA, CE marking, cGMP, cGCP, HIPPA, ICH Guidelines.

- ASQ certfication as Certified Quality Process Analyst (CQPA) (Certificate No. 1611).

- Proficient in MS Office: Outlook, PowerPoint, Excel, Word.

WORK EXPERIENCE:

Regulatory Intern Jan 2014 - present

USC Norris Cancer Centre

- Preparation of IRB submissions for oncology trials (New study, Continuing Reviews, Amendments, SAE Reporting)

- Assisting in preparation, submission, renewal & updating regulatory documents.

Jan 2011 – Jun 2012

Executive Grade I Clinical Research Associate (CRA)

Ashco Niulab Industries Ltd., Mumbai, India (Bioavailability / Bioequivalence studies)

- Designed Phase I protocols for anti-diabetic, anti-hypertensives, NSAIDS, statins, anti-viral drugs.

- Preparation of Informed Consent Form, Case Report Forms, Standard Operating Procedures and Trial Master File.

- Made Submissions to Drug Controller General of India, IEC Correspondence and Sponsor Communication.

- Trained new employees in in-house SOPs and cGCP.

PROJECTS:

Regulatory strategy to launch a US product in China market Spring 2014

Drafted the regulatory strategy considering the cultural, market competitiors, reimbursement and current developments in

China.

CMC section of IND for drug substance Fall 2013

Drafted Module 3 of CTD which mainly included characterization, manufacturing, container closure system, controlled

and reference standards and stability data.

Quality Audit Inspection Spring 2013

Audited SOPs for process verification and validation to make them comply with ISO 13485 and 21 CFR 820 standards.

Phase IV clinical study design Spring 2013

Designed double-blind randomized placebo controlled study of gabapentin tablets in prophylaxis of migraine headaches.

510 K application on implantable clip Fall 2012

Drafted a FDA Pre-Market Notification 510(k) for temporary Laparoscopic Hip Implant based on the available predicate

devices in the market.

Strategy to launch anti-obesity peptide in market. Fall 2012

Designed a clinical trial for launching anti-obesity drug. It included detailing of all the 4 phases i.e. sample size calculation,

study population, end points, post marketing surveillance plans, budgeting and strategically setting timelines for each

phase.

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