SMITA H. GEHANI

WORK EXPERIENCE

Technotech Inc - Contracted to AstraZeneca, MD

Jun 2014-Present

Associate Regulatory Documentation Manager

Identified, planned priorities, and interfaced with internal as well as

external stakeholders to ensure deliverables comply with AZ standards

Provided expert submission management and publishing support within the

Clinical function and also to external vendors

Partnered with colleagues within CSM globally for timely deliveries but

also in the development of new and innovative ways of working to drive

ongoing efficiencies in the CSM processes and use of tools

Worked collaboratively with other functions for delivery of submissions to

Health authorities

Provided clinical submission ready documents using various tools like GEL,

ANGEL(FirstDocs), eCTDXPress, ISIToolBox and Lorenz

Technotech Inc - Contracted to Taiho Pharmaceutical Co., LTD, NJ

Jun 2014-Dec 2014

Regulatory Affairs Publishing/Documentation Consultant

> Played an integral part in the preparation of technical regulatory

documents and managed the flow of documents

throughout the submission preparation and submission-review

processes by communicating with medical writing and

regulatory

> Responsible for formatting, publishing, and submission of regulatory

documents (IND, BLA, MAA, NDA,) in eCTD

format and coordination of submissions independently and in a team

setting in time-intensive situations

> Critically reviewed and QC'd hyperlinking/bookmarking of regulatory

documents using regulatory e-submission

software ViewPoint as well as Microsoft Office Suite, Adobe

Professional, Liquent-InSight and ISIToolBox.

> Edited complex, lengthy technical documents for clarity, grammar,

spelling, and punctuation; for adherence to

applicable regulatory and for consistency within the dossier

> Communicated with technical subject-matter experts to ensure that

content is delivered according to schedule and

provided status updates; coordinated and provided training on

documentation systems and tools; and collected

relevant submission related data

> Represented the Submission Support Group on Technical Regulatory Teams

and Technical Development Teams, as needed

Eclaro International - Contracted to Taiho Pharmaceutical Co., LTD, NJ

Mar-2014 - Jun 2014

Regulatory Affairs Publishing/Documentation Consultant

> Played an integral part in the preparation of technical regulatory

documents and managed the flow of documents

throughout the submission preparation and submission-review

processes by communicating with medical writing and

regulatory

> Responsible for formatting, publishing, and submission of regulatory

documents (IND, BLA, MAA, NDA,) in eCTD

format and coordination of submissions independently and in a team

setting in time-intensive situations

> Critically reviewed and QC'd hyperlinking/bookmarking of regulatory

documents using regulatory e-submission

software ViewPoint as well as Microsoft Office Suite, Adobe

Professional, Liquent-InSight and ISIToolBox.

> Edited complex, lengthy technical documents for clarity, grammar,

spelling, and punctuation; for adherence to

applicable regulatory and for consistency within the dossier

> Communicated with technical subject-matter experts to ensure that

content is delivered according to schedule and

provided status updates; coordinated and provided training on

documentation systems and tools; and collected

relevant submission related data

Represented the Submission Support Group on Technical Regulatory Teams and

Technical Development Teams, as needed

> Collaborated with internal partners like medical writing to ensure

submission readiness. Participated in Submission Support Group team

initiatives by providing input on future systems enhancements,

business process updates, publishing and submission model documents

Eclaro International - Contracted to Ikaria, NJ

Jun 2013-Feb 2014

Submissions Publisher \ Document Specialist

Supported submissions publishing and document preparation activities for

the R&D organization of medical devices using ISI Toolbox, Octagon's

Quantum, Submission Manager and ViewPoint.

Applied knowledge of international regulatory standards and expectations to

establish and promote best practices in the preparation of clinical and

regulatory submission documents

Performed all regulatory responsibilities in compliance with applicable

local and/or global regulatory standards (e.g. MHRA or FDA GLP regulations)

Published various types of submissions for drugs and devices, including

INDs, NDAs, 510(k)s (in CTD/eCTD format) - original submissions and

lifecycle support (including Annual Reports, Amendments, and Supplements)

Applied FDA/ International Regulations to provide input and guidance to

the organization

Liaised between regulatory and other areas of the organization

Eclaro International - Contracted to Pfizer Inc., NY

Hub Submission Manager

Jun 2011-May 2013

> Worked directly with Clinical Development Operations, Global CMC

Operations, Safety Surveillance, Pharmacologists and Strategists to

ensure quality and consistency of data and responses submitted as well as

facilitated team review and resolved issues of published output to meet

the deadlines

> Executed required dossier development build and publishing activities

like creating bookmarks, hyperlinks

> Delivered project specific paper and electronic lifecycle managed

submissions utilizing ISI ToolBox and eCTDXpress including co-ordination

and execution of publishing solutions that meet unique requirements of

IND, NDA and ANDA submissions, and management of product delivery to

regulatory agencies.

> Provided strategies to global CMC, global labeling and safety operations

in the process of filing submissions

> Prepared and submitted Amendments and Supplements (Labeling and CMC

Amendments, Prior Approval Supplements, PADERs, CBE-30 and CBE-0) for

NDAs and ANDAs along with clinical protocols, safety reports and annual

reports for INDs

> Coordinated the preparation and quality control of regulatory

applications and submissions in accordance with agency requirements.

Understood and followed regulations, guidelines and procedures.

Identified inconsistencies in routine and complex submissions

> Coordinated, managed and published major global submissions, including

NDA, IND and DMF applications, using Pfizer's eCTD System,, ISI

Publisher, ViewPoint, GDMS, Adobe Acrobat and associated plug-ins.

StriVectin Operating Company, NY

Regulatory Affairs Associate

Mar 2011-Jun 2011

Keep current with the various international country

submission/registration/approval and compliance requirements for marketing

StriVectin products domestically and in 50+ countries outside the U.S.A.

Maintain paper and electronic submission documents and databases in an

accurate and timely manner

Monitor pending and existing submissions/registrations to identify any

unexpected delays; initiate re-registrations to avoid disruption in product

availability by managing several dossiers

Obtain export certificates from FDA and arrange for authentication of

registration documents with state and federal authorities and foreign

government embassies and consulates as required for registration process

Cipla - Mumbai, India

Trainee/ Intern

Jun

2007-May 2008

Received training in GMP Regulations, Quality Assurance, CMC, CAPA,

documentation and auditing

Under supervision worked for drug analysis and drug safety using GCP, HPLC

and IR to meet regulatory requirements

EDUCATION

Long Island University - Brooklyn, NY Master of Science in Drug

Regulatory Affairs Dec 2010

National Institute of Health Clinical Research Training Course, MD

Aug 2010

Mumbai University, Maharashtra, India Bachelor of Science in Pharmaceutical

Science Jun 2008

Reference: Will be furnished upon request

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