PROFESSIONAL EXPERIENCE SUMMARY

Regulatory Affairs professional with extensive, multidisciplinary industry

experience and a proven ability to execute. Diverse range of expertise in

regulatory compliance, CMC, quality, manufacturing, pharmacovigilance,

clinical and non-clinical fields. Solid knowledge on US FDA, EU, ICH and

ISO regulations. Handled multiple clients' projects with high efficiency

as a regulatory affairs specialist.

WORK EXPERIENCE

Biovalorem, Indianapolis, USA December 2010

- Present

Senior Regulatory Affairs Specialist

. Developed Quality Management System (QMS) for a number of

pharmaceutical and biotech companies including preparing Quality

Manual, Standard Operating Procedures and other Quality tools.

. Conducted training on QMS, GMP, GLP, GDP and GCP to a number of

Pharmaceutical companies.

. Performed a Sponsor and Contract Research Organization (CRO) Partner

Assessment to select a CRO that can fit the requirements of the client,

using assessment tools.

. Assisted on New Drug Application (NDA) dossiers submission scheduling.

. Developed Clinical Study Report Template using ICH E3 regulation and

Clinical Study Protocol Template for a multisite clinical study.

. Prepared and coordinated submission of Annual Safety Reports to

regulatory agencies.

. Conducted FDA mock audits at a number of pharmaceutical companies on

Good Clinical Practices (GCP), Good Vigilance Practices (GVP), and Good

Manufacturing Practices (GMP) compliance.

. Developed training material on new Eudravigilance Guidelines and

assisted in training.

. Developed procedures, instruction, workflows and tools required for

Case processing, Safety Data Exchange, Aggregate Safety Reports,

Literature Surveillance, Product Information Maintenance & Safety

Variation Submissions., Safety Signal Management, Risk Management Plans

(RMP) or Risk Evaluation and Mitigation Strategy (REMS).

. Harmonized Pharmacovigilance department to comply with US and European

regulations including preparing procedures for post marketing reporting

for approved products.

. Developed a pharmacovigilance and clinical quality assurance key

performance indicators tracking tool for a multinational pharmaceutical

company.

. Prepared and coordinated NDA, BLA and CMC submissions to the FDA.

. Registered Over The Counter (OTC) drug products with FDA using

electronic submission gateway.

. Developed regulatory strategy for a number of drug products and

assisted in bringing the products onto the US market.

. Coordinated and consulted with cross-functional departments on the

content, review and assembly of regulatory documentation.

. Assisted on Global Regulatory Affairs audit at a multinational

pharmaceutical company to ensure compliance with global regulations.

. Developed unique risk assessment tools to conduct risk based audits of

the pharmaceutical and clinical sites.

. Developed monitoring and auditing tools for Investigative Sites using

ICH E6 regulations and US FDA BIMO regulations, Sponsors and Contract

Research Organizations using ICH E6 regulation and US FDA BIMO

regulations, Medical Laboratories using ISO 15189 standard, Medical

Devices establishment using ISO 13485 standard and Institutional Review

Board using US FDA and HHS regulations and conducted audits using these

tools.

. Developed Vendor Management System including the qualification,

auditing, execution and monitoring procedures and tools to track the

performance.

. Developed Corrective and Preventive Action (CAPA) solution to assess

the impact of non-conformities, determine the root cause, plan and

implement.

. Prepared validation strategy and performed validation of various

softwares that assist in tracking pharmaceutical manufacturing

performance indicators.

. Developed project management tools and templates to track various

projects being undertaken and successfully tracked the projects and

their progress.

. Assisted in prepared training material for Project Management

Professional (PMP) certification and training various groups.

Borra Health Care Pvt. Ltd., Hyderabad, India April

2009 - September 2010

Regulatory Affairs Associate

. Handled change control procedures, Deviations, Failure Investigation &

implementation of CAPA.

. Prepared SOP's, Batch Manufacturing Records (BMR), Batch Packing

Record, Annual Product review, Trending of Quality Parameters of API.

. In-process Quality Assurance: Line Clearance, Sampling of In-process

and finished product Sampling of Validation batch samples, In-process

checks, Batch Processing Record review, product release to market, Log

books of preventive maintenance of equipment's, daily usage log books

review.

. Prepared checklists for internal quality audits and assisted on the

internal audits.

SR College of Pharmacy, Warangal, India June 2006 - May

2007

Teaching Assistant in Biochemistry Laboratory

. Assisted in Biochemistry laboratory for conduct of various experiments

and analyzed the results.

CERTIFICATIONS

. Achieved Certified Clinical Research Professional (CCRP) certificate

offered by SOCRA.

. Achieved certificates of completion by accomplishing training modules

offered by the U.S. FDA under

o CDRH Learn - QSR, PMN, Recall management, Establishment

Registration and Listing

o CDER Learn - Drug regulation, labeling, compliance, and risk

assessment etc

EDUCATION

Master of Science, Regulatory Affairs in Drugs, Biologics and Medical

Devices

Northeastern University, USA

Bachelor of Pharmacy

Kakatiya University, India

PUBLICATIONS

"Effect of Excipients on Chloroquine Phosphate Tablets" Journal of

Pharmacy Research. Oct 2009, Vol. 2 Issue 10, p1648-1652.

ACADEMIC PROJECTS

. Prepared, Reviewed and submitted an IND Document, BLA and 510(K) in

class setting

. Interpreted FDA Warning Letters issued to various companies and

replied to them as part of the course work

. Prepared sample Informed Consent documents for various phases of a

clinical trial of a novel drug

. Submitted a position paper on "Tobacco Industry: Positives,

Negatives, Approach of the FDA and Congress"

. Submitted a position paper on "Reusing Single Use Medical Devices"

. Submitted a paper on "The Role of Midlevel Practitioners (Nurse

Practitioner, Physician Assistants and Pharmacists) in HealthCare

Delivery and Patient Access"

. Submitted a paper on "Impact of PPACA Provisions on Patients and

Insurance Companies"

. Worked on the project "Combination Products and Challenges of

Convergence" and presented the project

. Worked on the mini project "Reimbursement for Combination Products"

COMPUTER SKILLS

. MS Office suite of products like Excel, PowerPoint, Word, Visio

. MS Project

. OS like Windows, Mac iOS

. Adobe Acrobat Pro

. SharePoint

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