Regulatory Affairs Specialist

Richa Padhya

**** ********** **** ***#**, San Diego, CA-92126

Contact: 858-***-**** Email: ***********@*****.***

Objective:

Seeking better opportunity in industries to contribute towards industrial and personal growth.

Education:

Master in Regulatory affairs Dec 2015

San Diego State University GPA 3.54

Master of Pharmacy (Industrial Pharmacy) May 2011

S. K. Patel College of Pharmaceutical Education & Research, Gujarat, India GPA: 3.71

Bachelor of Pharmacy- Registered Pharmacist May 2009

S. K. Patel College of Pharmaceutical Education & Research, Gujarat, India GPA 3.65

Qualification:

Extensive education and experience in Pharmaceutical & Medical device Regulatory fields

Knowledge and experience of US, Europe, Canada, Australia and Latin America’s regulation

Developing Regulatory strategy and evaluate regulatory impact for new product or new changes

Experience to work and effectively communicate with different regulatory agencies

Knowledge and experience working on of all Pre-market approval process – 510 (K), eCTD submission for IND

Experience of attaining and running regulatory audits (Notified body Audit from Europe, FDB Audit)

European marketing Approval planning and approval

Experience about some important aspects of Quality Assurance and thorough knowledge about cGMP, GLP, GCP, Quality System Regulation (21 CFR 820 ) ISO 13485, ISO 9001 quality standards, ICH guideline and other FDA guidelines

Technical Skills:

Good communication and writing skill

Ability to manage multiple projects simultaneously

Ability to prioritize and meet deadlines.

Good proofreading and technical writing skill

Good Computer skills MS Word, MS Excel, and Adobe Acrobat, Oracle, Objective, Microsoft project planning, PharmaREADY for eCTD submission

Familiar with the various Regulatory agencies website and databases like FDA, ARTG, Health Canada

Experience:

Regulatory Affairs Associate, ResMed, San Diego, CA March 2016- Present

Major responsibilities and activities include:

Dossier preparation and submission in Latin America countries (16 Submissions)

Registration and Renewal of regulatory Licenses

Quality Policy changes and document control activity

Electronic submission to FDA

Import for Export case follow up and Sales order regulatory approval

Certificate of foreign government request & FOIA (Legalization & apostille)

RA/QA Manager, ENTRA HEALTH, San Diego, CA June 2015- February 2016

Major responsibilities and activities include:

Regulatory submission including Traditional and special 510(K) IVD devices (K143169)

Development of Regulatory strategy and planning

Label review and approval as per Regulatory requirement

Regulatory compliance of for Software as a Medical device and mobile application (IEC 62304)

Technical file and dossier preparation and submission for Europe

Health Canada and TGA approval and submission

510(K) submission planning and approval- Traditional and special 510(K)

FDA response to RTA hold for 510(K)

Post market surveillance activity (Complaint reporting, MDR filling)

Design control, Device master record- Design History file development and maintenance

Gap analysis and change implementation

Create or improve of Quality Procedure (SOPs) and implementation by follow up training - QSR

Corrective and preventive action (CAPA) and Identify nonconformance

Change control management

Risk assessment and risk management planning (FMEA- ISO 14971)

Audit Activities (FDA, Notified Body, Customer) and perform Internal audits and training

RA/QA Specialist, Entra Health, San Diego, CA April 2015-May 2015

Major responsibilities and activities include:

Complaint/adverse event evaluation, trending the type of complaint from Salesforce, zoom etc.

MDR Reporting for USA, EU Pharmacovigilance reporting, Complaint reporting to other international markets like Canada, Australia

RA/QA Specialist, Maan Pharmaceuticals LTD., India August 2011- Oct 2012

Major responsibilities and activities include:

Responsible to support to create, validate, correct and submit eCTD to FDA and have experienced working with EDMS (electronic data management system) software ( IND Application )

Responsible to support in preparation clinical trial protocol and necessary information for phase II and III trials

analyze trial protocols as a part of drug development process

Quality Assurance Intern, Welable Pharmaceutical, India Jan 2011- March 2011

Major responsibilities and activities include,

Electronic Quality documents Management

Quality assurance inspection ( cGMP compliance)

Master in Regulatory affairs, San Diego State University

Course Work:

Effective Medical/Scientific Writing, Quality improvement management with some useful tools, FDA regulation, International Medical Regulations (USA, Europe, Canada, Mexico, Japan, Australia, China, and India), current good manufacturing practice (cGMP), Drug development and approval processes (INDA,NDA,ANDA), Medical device regulation (IDE, 510(K), PMA, CE certification), Biological product regulation (BLA), Preparation of Dossier, e-CTD, Clinical trials and issues in design, conduct and evaluation, Project Planning, change control, Risk management & Quality by design.

Academic Projects:

Regulatory aspects of Quality by Design – Capstone Project

Effective communication and technical writing

Risk management and assessment planning

Drafting compliance papers on several FDA warning letter & recalls.

Response to FDA warning letter

API and finished dosage form paper, including CGMP requirement and import regulations

Drafting and analysis of a complete clinical trial protocol, Informed Consent Form

References:

Available on request

Contact this candidate