Quality Control Assurance

Zahabia (Zee) Adenwalla

****************@*****.*** 617-***-****

RegulatoryAffairs: Pharmacist with experience in healthcare industry,

primarily in the area of providing regulatory strategy to support early

development registration and life-cycle management submissions, preparation

of registration and life-cycle management submissions. good quality dossier

components, submissions to authorities in the major world markets in order

to obtain and maintain approvals for regulatory submission documentation

(NDAs, MAAs, INDs, CTAs, eCTDs)

CORE COMPETENCIES

Regulatory Affairs eCTD Submissions Quality and Compliance

Life Sciences Application Hands-on Experience

eCTD Submission, eCTD Validator, eCTD Viewer

Coredossier or eCTDExpress

CESP- Common European Submission Platform

Viewpoint, First Documentum System, GFS, NOVOS

ISI Toolbox (with proven background in bookmarking and Hyperlink, page

stamp, masking and watermarks etc), ISI writer

CAREER HIGHLIGHTS

Amdipharm Mercury (AMCo) Group (U.K)

Executive -Regulatory Affairs

March 2011 -August 2014

Regulatory stratergies and Operations: Develop, support and execute

complex regulatory strategies throughout the product lifecycle and

effectively communicating global regulatory strategy and other important

issues. Prepare, review, evaluate, format, and edit documents for

regulatory submissions to ensure accuracy, compliance, track and coordinate

regulatory submission activities to ensure timelines and commitments are

met.

eCTD submissions: Responsible for building XML documents and in-depth

understanding of the eCTD structure, using Extedo software and Responsible

for eCTD publishing utilizing MS Word, Adobe Acrobat, ISIToolbox and/or

other PDF publishing toolset. Managed and executed all aspect of and all

types of submission/ePublishing projects working globally across multiple

therapeutic areas.

Dossiers: Responsible for the development and submission of product

dossiers and ensure the dossier design, assess regulatory compliance and

ensure timely submission of dossiers to competant regulatory authorities.

Licenses : Responsible for the licensing process which included preparation

and submission of documentation to Regualtory authorities in delivering

project specific company's paper and electronic submissions. Maintained

records of required compliance certificates whereever appropriate

Zahabia Adenwalla - Page 2

Regulatory Labeling: Provide Regulatory support in the development,

revision, review, and labeling for accuracy. Supported in implementing

regulatory strategies for labeling development to support successful

commercialization of products.

Regulatory Intelligence: Developing and maintaining accuracy of all

documentation prepared and where appropriate submitted to regulatory

authorities and work with subject matter experts to develop clear and

concise regulatory strategies. Keep abreast of changes, trends and

developments to the regulatory environment.

Audits: Succesfully participated in 2 EMEA inspections in the past 2 years.

Maintained and comply with current defined procedures and regulations for

inspection readiness, internal audits and external audits.

Scientific Pharmaceuticals

Quality Control/ Quality Assurance and Regulatory Associate

May 2010 -July 2011

Role:

Quality control of various drugs which were manufactured tested and checked

for labelling instructions.

Ensured quantitative validation of drug substances and drug products and

maintained related documentation.

Knowledgeable of collecting data required for chemistry, manufacturing and

control (CMC) as a part of ANDA submissions and handling of various Drug

Master Files (DMF).

Society medical stores, Mumbai

Trainee

May 2008- August

2008

Role:

500 hours of internship in retailing, sales and marketing of pharmaceutical

products.

Performed services related to the preparation and dispensing of drugs and

other pharmaceutical supplies in accordance with physician prescriptions.

Establishing and maintaining an excellent client relationship, providing

prescription expertise, this result in several letters from customers

stating excellent customer satisfaction.

Zahabia Adenwalla - Page 3

EDUCATION

Northeastern University, Boston MA

Masters of Science, Regulatory Affairs (Expected)

Specialization: Drugs, Biologics, Medical Devices

NMiMS University

Bachelors of Pharmacy

University of Mumbai

Diploma, Pharmaceutical Sciences

professional credentials

Pharmacist

Contact this candidate