Management Medical

Education

Master of Business Administration

May 2013 - Present

Goldey-Beacom College, Wilmington, DE

Master of Science in Drug Regulatory Affairs

2012

Northeastern University, Boston, MA

Bachelor of Pharmacy

2009

Rajiv Gandhi University of Health Sciences, Bangalore, India

Professional Experience

Regulatory Affairs Consultant

Pharmalink Consulting, New Jersey, USA

July 2013 - Dec 2014

. Responsible for effectively updating Pfizer CMC regulatory

documentation databases and dossier management systems.

. Interaction with the Global and Regional Regulatory Team (HUBs

colleagues, product principal, country strategist, other country PCOs)

in order to gather information regarding various product approvals.

. Submission of Post Approval changes to the Regulatory bodies (EU, ROW)

. Coordinating tasks effectively for closure of compliance issues and

regulatory notifications.

. Reviewing and assisting global post approval CMC change management

data and Delivering CMC information for regulatory submissions.

. Assist with the compilation of documentation for CMC regulatory

submissions in support of global marketing applications.

Documentation Control Specialist,

Ohm Laboratories Inc. (A Ranbaxy Group Company), New Jersey, USA

July 2012-March 2013

. Reviewed documents including SOPs, analytical procedures, validation

and stability protocols.

. Maintained product core dossier and product master files.

. Preparation, Review and updating the technical documents like key QA-

SOPs, Batch Manufacturing Records, Change control, Deviation etc.

. Assessed change controls and prepared submissions arising from the

change control process.

. Reviewing and reporting QA/QC documents as a part of CAPA.

. Headed the documentation procedures for Reduced Testing and Vendor

Qualification.

Skill Set Summary

Regulatory Skills

. Prepared, interpreted and reviewed effective regulatory strategies

utilizing 510(k), PMA, IDE, PDP submission processes in an eCTD format

for new and revised medical devices and in vitro diagnostic devices in

a class setting.

. Attained wholesome knowledge on cGMP, cGLP, cGDP and GAMP guidelines,

and 21 CFR Parts 11, 50, 56, 58, 210, 211, 312, 314, 820 and ISO

13485.

. Comprehensive examination of case studies in four primary areas of IP

law - patents, copyrights, trademarks, and trade secrets in the

context of biomedical product development.

. Gained extensive knowledge on regulatory processes pertaining to

Pharmaceutical drugs (IND, NDA & ANDA) & Biologic's (BLA).

. Profound knowledge on methodological issues fundamental to clinical

trials, IRB submissions, investigator brochures, Trial Master Files

and prepared sample inform consent documents, clinical trial protocols

and case report forms.

. Proficient with policies and procedures pertaining to the

international markets (Europe, Canada, Australia and Latin America).

As a part of class project, coordinated and developed an effective

international regulatory submission by observing all the regulatory

functions and regulatory incentives to facilitate an easy marketing

clearance.

. Sound understanding on labeling requirements (CDRH-OC) for container

label/package insert/medication guide & promotional labeling. In a

class setting reviewed and assessed labeling features for sample

medical devices by ensuring compliance with regulatory standards. Well

versed with advertising and promotional regulations (21 CFR 202).

Technical Skills

. Operating Systems: Windows XP/2000, Mac 0SX, Mac OS 8.6

. Expertise in MS word, MS Excel, MS Access, MS PowerPoint, and Adobe

Acrobat

Certifications and Affiliations

. 'Registered Pharmacist' certified by 'Pharmacy Council of India'

-December 2009.

. Achieved certificates of completion by accomplishing training modules

offered by the U.S. FDA under

1) CDRH Learn - QSR, PMN, Recall management, Establishment Registration and

Listing

2) CDER Learn - Drug regulation, labeling, compliance, and risk assessment.

. Active member of RAPS (Regulatory Affairs Professional Society).

Contact this candidate