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Regulatory Publishing - Senior Associate

Location:
India
Posted:
November 08, 2016

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VEENA

(A.k.a. G. Veena, Golla Veena)

Email: acxe6d@r.postjobfree.com Mobile: +917829061977

I am G. Veena, having around 4.1 years of experience in the field of Pharmaceutical Regulatory Operation Submissions for Regulatory Markets like US, EU and ROW markets. Currently, I am working as a Senior Associate - Regulatory Publishing Department in KINAPSE LIFE SCIENCES PVT. LTD., Bangalore.

Prior to KINAPSE LIFE SCIENCES, I have worked with ACCENTURE LIFE SCIENCES Bangalore, India. I have acquired my experience in the functions of Regulatory Operations, Business development and Project management.

I have imbibed the work ethics, values and systems of the Organization. Therefore, my contribution to the organization, where I have worked has been meaningful, substantial and professionally contributing.

Now, I wish to take up assignments with wider scope and challenging aspects that contributes for the organizations and potential for self-fulfilment.

Thank You,

G. VEENA.

OBJECTIVE:

To seek a challenging career in a progressive organization to integrate my skills and services to the organizational and personal growth. I can put my hard effort and my knowledge and I assure you that I shall perform all the duties assigned to the best of my ability at all levels.

Strengths Creativity, Commitment and Team Spirit are my talents of technical services & general management allow me to add value to the operations execute

TOOLS EXPERIENCE:

•ISI Publisher & eCTD Express

•Extedo eCTD Manager

•View Point & Quantum

•Common European Submission platform (CESP)

•FDA ESG Gateway

•EMA Gateway

•Liquent Insight manager (RIMS).

•EURS Extedo Validator

•Global Validator

•Lorenz Validator

•Mydoc

.

PROFESSIONAL EXPERIENCE:

KINAPSE LIFE SCIENCES PVT LTD – SENIOR REGULATORY ASSOCIATE

(Bangalore, India – 1 April 2014 – Present)

•Publishing dossiers in eCTD/CTD/NeeS format for submission to ministry of health Europe, US, Canada and ASEAN markets for the registration purpose of drug products. Well-versed with ICH-GCP guidelines and regulatory guidelines.

•Worked on Responses to Queries, MAA, Variations, PSUR, DSUR, IMPD, IB in the EU and ASEAN, ROW markets and also IND, NDA Annual reports, Supplements (CBE-30, CBE-0), Labelling supplements, PADER in the US market.

•Generate Validation reports for eCTD Submissions using Lorenz e Validator for US and using EURS Validator for EU Countries.

•Providing support to publish NeeS Format/CTD/eCTD Dossier submission in EMEA Agencies as per ICH-GCP guidelines.

•Providing support to publish NeeS/CTD/eCTD Dossier submissions to South Africa: Department of Health adhering to MCC Guidelines and also to Saudi Food & Drug Authority following GCC Guidelines.

•Upload files from Mydoc into eCTD XPress in which file tagging, leaf title change, create inter-documents Hyperlinks, QC, and QC corrections, for eCTD submission are performed.

•Dossier Submission to EU Health Authorities via Common European Submission platform (National, MRP and DCP) and Centralized Procedure using EMA Gateway, worked on FDA ESG Gateway to dispatch submissions to FDA.

•Editing and Reviewing PDF/Word-documents quality as per agencies requirements\expectations.

•Render the Word files into PDFs.

•Ensuring consistency of documents received and archived

•Archiving the documents as per Daily Report activity in the database of the company as per Post Authorization.

•Worked with Clients closely to find and resolve all submission related issues.

•Participate and present ideas for the development of processes.

RECOGNITION AND AWARDS:

•I have been promoted to Senior Associate level with in a year for taking up challenges in work adhering to quality always with in the submission timelines.

•I was appreciated and recognized for delivering presentations for departmental sustainment training and new hire training.

•I was recognized for being a scribe and also taking active participation during Client Audits.

ACCENTURE LIFE SCIENCES PVT LTD (OCTAGON CLINICAL RESEARCH SOLUTIONS PVT. LTD.)

ASSOCIATE, REGULATORY OPERATIONS (Bangalore, India - 13 August 2012 – 31 March 2014)

•Manage daily tasks associated with publishing regulatory submissions, including bookmarking, hyperlinking and quality control of submission PDF files in accordance with FDA guidelines and other authorities.

•Understand and follow internal standards including standard operating procedures, guidance documents, and policies throughout the lifecycle of the submission.

•Create and verify bookmark structure and hyperlinks to ensure submission-readiness.

•Perform document-level and final quality control reviews of submission PDF files.

•Work with Document Coordinator to find and resolve all submission related issues.

•Perform corrective action and verification for submission PDF files.

•Manage workflows for basic publishing and document image enhancement.

•Organize folders/files to build electronic submissions.

•Create electronic media for client or submission deliverables.

•Participate in the development of internal projects.

•Create and deliver presentations for departmental sustainment training and new hire training.

•Be prepared to deploy on-site to support eSUB projects.

•Walk a client through the overall publishing process and an explanation of the publishing tools and tasks used to produce electronic submissions.

RECOGNITION AND AWARDS:

•I was recognized for embracing changes with agility and adaptability

•I was rewarded for achieving goals and openly sharing ideas, knowledge and resources.

•I was greatly appreciated by the leadership team for my presentation dynamics in townhall meetings

PUBLICATIONS/PRESENTATIONS:

•Published “Effect of Losartan Potassium on the Solubility of Hydrochlorothiazide by Solid Dispersion Technique.” Article in “Journal of Chemical and Pharmaceutical Research” J. Chem. Pharm. Res., 2011, 3(4):150-158.

•Achieved “Best Poster Presentation” award for “Pharmaceutical Formulation and Evaluation of Tablets” which was held at GIET, Rajahmundry.

•Participated in National Level Workshop on “Clinical Trials and Medical Informatics held in the Department of Biomedical Engineering at GIET, Rajahmundry (BIO MEDZ-August 2008).

COMPUTER SKILLS:

•Adobe Acrobat and ISI Toolbox

•MS Office

•Excel

CERTIFIED COURSES:

•Advanced PG diploma in clinical trials & Clinical Data Management Training specialized in ICH-GCP guidelines, Pharmacovigilance, CDM & SAS Clinical in BioMed Informatics Medwin Hospitals, Hyderabad

SCHOLASTIC ACHIEVEMENTS:

•Secured college first in M.pharmacy and second at University level and college second in the Second semester.

•Stood FIRST rank in B. Pharm degree at College Level with overall percentage of 77.60%.

•Qualified in PGECET-2009 with rank 274.

•Secured school first in tenth class public exams.

EDUCATION/TRAINING:

•Master of Pharmacy, Pharmaceutics, NOVA College of Pharmacy, Jangareddy gudem (Affiliated to Jawaharlal Technological University - Kakinada), A.P, India, Year 2011.

•Bachelor of Pharmacy, GIET School of Pharmacy (Affiliated to Andhra University), Rajanagaram, Rajahmundry, Andhra Pradesh, India, Year 2009.

•Intermediate in Aditya Junior College, Rajahmundry, Year 2005.

•S.S.C. in Pratibha Public School, Rajahmundry. Year 2003.

PERSONAL PROFILE:

Name : Veena Golla

Father’s Name : G.U.V.B.Raju

Date of Birth : 13th November 1987

Languages Known : English, Hindi and Telugu

Marital Status : Un-Married

Permanent Address : Weavers Colony, D.No:24-3-9,

Rajahmundry, East Godavari Dist -533105

Mobile : +91-782*******



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