Hi, I’m
ANUSHANANDINI DEVARAKONDA
Bengaluru
Summary
- A dynamic professional with around 5 years of experience in Regulatory Affairs Operations (Publishing) supporting diverse markets including US, Europe, Canada, and Australia.
- Proficient in handling Insight Publisher tool, EXtedo eCTD Manager, LORENZ docuBridge, validation tools and document publishing tools for over 5 years.
- Currently associated with Parexel Consulting as Associate – Regulatory Affairs.
- Comprehensive experience in publishing of module 4 and module 5 documents for US Submissions.
- Expertise in document publishing tools such as Acrobat Professional and ISI Toolbox for Bookmarking, hyperlinking, and making document submission compliant.
Overview
5
years of professional experience
1
Certification
Work History
Parexel International India Safety Services Private LimitedBengaluru
Regulatory Affairs Associate – Publishing & Submission
03.2021 - Current
Job overview
- Headed a team of 6 people, the day-to-day operations and workload of the site publishing team and ensures that individuals are occupied with work
- Built various submissions within Extedo eCTD Manager for NDA, IND, and BLA applications
- Imported submission ready files from an Electronic Document Management System into their specific module folders, file tagging, leaf title modification, bookmarking and hyperlinking, quality assurance and compilation
- Worked on the building, publishing, reviewing, and compiling of electronic IND and BLA submissions including Annual Report, DSUR, New Protocols, Protocol Amendments, IND Safety Reports, PADER/PBER, Information Amendments, Investigator Brochures, Ad/Promo, and various other documents submitted routinely to the FDA
- Analyzing data and deliver metrics per expected Key Performance Indicators for the entire team
- Gathered, coordinated, and submitted to the FDA all IND/BLA maintenance documents (i.e, clinical protocols, clinical protocol amendments, pharmacology/toxicology reports, clinical study reports and all post marketing reports and commitments)
- Developed and/or reviewed regulatory documents to ensure that all submissions are complete, accurate, and meet relevant requirements according to ICH and FDA guidelines
- Responsible for the final check and dispatch of the submission through ESG/CESP and Syncplicity (EMEA) Gateways
- Ensured a streamlined process for publishing and document control by developing and maintaining procedures and authoring SOPs where needed.
Relicare Tech Services (An Adcock Ingram Company)Bangalore
Officer – Regulatory Affairs
03.2019 - 03.2021
Job overview
- Compilation and Review of a CTD/e-CTD dossier for South Africa (SAHPRA) and African countries within the time frame
- Variations filing (Amendments) for South Africa as per the prescribed guidelines in EMA
- Review of DMF/CEP and all other relevant documents required to compile the dossier according to specific country requirement
- Responding to queries and submitting the response in the stipulated timeline
- Expertise in working with Lorenz docuBridge for compilation of various submissions
- Handling efficiently validation tools such as Lorenz and EURS
- Reviewing the final documents as per the document standards and creating navigation in PDF documents using ISI ToolBox
- Performing internal as well as external hyperlinking task for the published output document and validation of the submission
- Familiarity with Regulatory Operations (eCTD & NeeS) and Structured Product Labeling (SPL)
- Performing document transfer tasks such as archival, tracking and transfer of regulatory submission documentation
- Coordinate with various cross functional teams for documents, collate and review primary data received from different departments towards regulatory dossier compilation.
Education
Priyadharsini College of PharmacyGuntur
Master of Pharmacy from Pharmaceutical Analysis
05-2018
University Overview
- Percentage: 79%
- Board: Acharya Nagarjuna University
Hindhu College of PharmacyGuntur
B. Pharmacy
05-2016
University Overview
- Percentage: 80%
- Board: Acharya Nagarjuna University
Intermediate (Bi.P.C)Guntur
03-2011
University Overview
- Percentage: 86%
- Board: Board of Intermediate Education
Sarada Public School
High School Diploma
03-2009
University Overview
- Percentage: 86%
- Board: Board of Secondary Education
Skills
- Strong Leadership Skills
- Effective Time Management
- Effective Project Management Skills
- Ability to Multitask
- Critical Thinking and Problem Solving
- Ability to Work Under Pressure
- Strong Numerical Skills
Career Aspiration
Seeking a challenging opportunity in Regulatory Affairs Operations to foster my intellectual ability and professional growth and provide me with an overall expertise in Regulatory Affairs Operation's strategy, issues, and planning.
Certification
- eCTD Manager
- LIQUENT InSight Publisher 6.1 (Parexel)
- LIQUENT InSight for Viewing (Parexel)
- Lorenz docuBridge
- ISI ToolBox (Image Solutions, Inc.)
- SmartDesk for PDF
Languages
English
First Language
English
Proficient (C2)
C2
Telugu
Proficient (C2)
C2
Hindi
Elementary (A2)
A2
References
References available upon request.
Accomplishments
Country Manager’s Recognition program for Season 2 – 2023,
Bengaluru
Nominated for the India Country Manager’s Recognition program
for Season 2 – 2023, in the Team Category award for Driving India’s
Mission and Vision
Personal Detailes
Address: House No.72, D.No:9, FF, 12th, Main, 1st Cross, Jubilee College, Road, NR Layout, Kalkere, Bengaluru, 560016, India.
Date of Birth: 04-05-1994
Gender: Female
Nationality: Indian
Marital status: Married
Disclaimer
I hereby declare that the details furnished above are true to the best of my knowledge.
Timeline
Regulatory Affairs Associate – Publishing & Submission
Parexel International India Safety Services Private Limited
03.2021 - Current
Officer – Regulatory Affairs
Relicare Tech Services (An Adcock Ingram Company)
03.2019 - 03.2021
Priyadharsini College of Pharmacy
Master of Pharmacy from Pharmaceutical Analysis
Hindhu College of Pharmacy
B. Pharmacy
Intermediate (Bi.P.C)
Sarada Public School
High School Diploma
- eCTD Manager
- LIQUENT InSight Publisher 6.1 (Parexel)
- LIQUENT InSight for Viewing (Parexel)
- Lorenz docuBridge
- ISI ToolBox (Image Solutions, Inc.)
- SmartDesk for PDF
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