Communication, Organization, Project Management, Team work

VEENA GOLLA

Email: *****.*****@*****.*** Mobile: +917*********

I am G. Veena, having around 10 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 Regulatory Scientist - Publishing Department in SYNEOS HEALTH, Bangalore, India.

Prior to SYNEOS HEALTH (formerly as 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)

•Veeva Vault

•FDA ESG Gateway

•EMA Gateway

•Liquent Insight manager (RIMS).

•EURS Extedo Validator

•Global Validator

•Lorenz Validator

•Mydoc

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PROFESSIONAL EXPERIENCE:

SYNEOS HEALTH – SENIOR REGULATORY SCIENTIST

(Bangalore, india – 1 April 2021 – Present)

Manages project deliverables in line with project plan

Proactively identifies moderately complex issues and risks to project delivery in own work or work of the team and escalates appropriately with associated resolution proposals

Undertakes project specific activities independently and within cost and time estimates

Responsible for process implementation and ensure process compliance

Participate in meetings with Client on a regular basis to understand the client’s requirement for a particular project and proactively support the team in meeting or exceeding the targets in terms of quality, quantity within the scope of time constraints

Applies negotiation skills to recommend timelines and change in requirements

Act as a subject matter expert and help the team members with day-to-day trouble shooting activities

Responsible for creating or updating the SOPs, job aids as per project specific requirements

Reviews and provides solutions for issues relating to project delivery or escalates appropriately to the Team Leader/Program Leader/Program Director as required

Seeks opportunities to increase internal client satisfaction and deepen client relationships

Provide training and mentoring of team members depending upon the project requirement

KINAPSE LIFE SCIENCES PVT LTD – REGULATORY SCIENTIST

(Bangalore, India – 1 April 2017 – 31 March 2021)

As a Regulatory Scientist I have coordinated the preparation and quality control of regulatory applications and submissions with publisher, eCTD Express, Extedo, ISI Toolbox and various other types of submission software.

Provide input and advice to project leads and clients on “submission readiness” requirements for document components.

Supporting the client in aligning the process maps/SOPs/WI as per recent updates.

Liaise with the team members (Regulatory Operations, Regulatory Affairs) to ensure documentations meet the regulatory requirements and preparation, QC, publishing of regulatory documents.

Demonstrated technical knowledge for troubleshooting, monitoring/reporting issues, and interact with IT support. Also involved in group to evaluate other publishing software’s on a publishing and technical aspects.

KINAPSE LIFE SCIENCES PVT LTD – SENIOR REGULATORY ASSOCIATE

(Bangalore, India – 1 April 2014 – 31 March 2017)

•Publishing dossiers in eCTD/CTD/NeeS format for submission to ministry of health Europe, US, Canada and ASEAN markets (Hongkong, Singapore & Malaysian 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 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

Husband Name : Vamshi Krishna Baline

Date of Birth : 13th November 1987

Languages Known : English, Hindi and Telugu

Marital Status : Married

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

Rajahmundry, East Godavari Dist -533105

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

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