Abhishek Tyagi
Bangalore, Karnataka, India

About Abhishek Tyagi

Abhishek Tyagi works as Assistant Manager - Regulatory Operations (eCTD, NeeS & Paper publishing) at Freyr Software Solutions, Hyderabad, India and is based in Bangalore, India. Abhishek studied Master of Science (Biotechnology) at Cape Institute of Technology (2010-2012). On Youth4work, Abhishek has taken skill tests in Publishing (rank 16 of 1,613, top 1%). Abhishek also lists talents in Regulatory Affairs and Regulatory Compliance Officer.

Talents
    • Publishing
      ... among ... users in Bangalore
      16
      among 1613 users worldwide
      83.78
      percentile among worldwide users
    • Regulatory Affairs
      ... among ... users in Bangalore
      …
      among … users worldwide
    • Regulatory Compliance Officer
      ... among ... users in Bangalore
      …
      among … users worldwide
Professional Path
Assistant Manager - Regulatory Operations (eCTD, NeeS & Paper publishing)
Freyr Software Solutions, Hyderabad, India Full Time
Apr-2014 To present 12 years 5 months
  • • Organization & Preaparation of Metadata Form, Submission Request Form & Tracking tool for Regulatory US, SwissMedic, GCC and EU-CP eCTD submissions.
    • Publishing, building structure, compilation, quality performance and validations of dossiers (both eCTD & NeeS) using eCTDxpress, ISI Publisher, Lorenz evalidator and Extedo EURS validator & their submission to Health Authorities (USFDA, EMA) via GSG gateway.
    • Original submissions and Lifecycle maintenance of dossier.
    • Create and verify bookmark structure and hyperlinks to ensure submission readiness.
    • Archival submissions.
    • Follow-up with Global Colleagues for collections of documents and other submissions related data to complete the submission on time to meet Health Authorities timelines.
    • Assist to client for process optimization.
    • Assist to client for resource management & new reource requirements.
    • Training of new resources.
    • Assist to client for resource management & new reource requirements.
  • • Awarded at Freyr for performing beyond expectations at Client on-site.
Regulatory Analyst - Electronic submission specialist
Accenture (Accelerated R&D and Regulatory services), Bangalore, India Full Time
May-2013 To Apr-2014 11 months
  • • Publishing of eCTD dossiers.
    • Handling multiple clients (i.e. around 30+ clients) at a time, and managing multiple priorities under pressure of time and workload.
    • Planning of submission timelines with client, acting as single point of contact (SPOC) for client communications and project deliverables.
    • Perform document level and final quality control reviews of submission PDF files.
    • Create and verify bookmark structure and hyperlinks to ensure submission readiness.
    • Work with document co-ordinator to find and resolve all submission related issues.
    • Organize folders/ files to build electronic submissions.
    • Participate in the development of internal projects.
    • Daily Accenture and client specific training and exercise practice.
  • • Awarded as “FY 14 Good Samaritan Winners” for contributing significantly towards the production work, maintaining very high quality (FTR 99%) and turning around tasks quickly.
    • Highly appreciated by Leadership team during “Client visit for Presentation on eCTD end to end Process” infront of clients (Merck visit and AstraZeneca visit).
Regulatory Associate - Regulatory Publishing (eCTD/Nees/Paper).
Take Solutions Global LLP, Chennai, India Full Time
Jul-2012 To Apr-2013 9 months
  • • Publishing, building structure, compilation, validations and quality performance of dossiers (both eCTD & NeeS) using eCTDxpress and ISI Publisher.
    • Archival submissions using RADARS.
    • Training for new joiners.
    • Daily Pfizer training and exercise practice.
  • • Awarded as Best Publisher of the Year 2012- 2013 by Pfizer for maximum numbers of submission with highest Quality.
Senior Chemist (Regulatory Affairs)
ectar Lifesciences Limited (USFDA, CEP & EU-GMP Approved facility), Chandigarh, India Full Time
Nov-2010 To Jun-2012 1 years 7 months
  • • Responsible for preparation of Drug Master Files, Applicant’s part for US-FDA, EMA, K-FDA, ANVISA, ROW markets and domestic markets.
    • Succesfully done errors/ warnings free publishing, building structure, compilation and validation of dossiers using Lorenz docubridge and Lorenz evalidator).
    • Maintenance and updattion of Vendor’s documentation.
    • Preparation of Product profiles for APIs and intermediates.
    • Review of technical documents like Specifications, Standard test procedures, Batch manufacturing records for adequacy
    • CoPP and Drug Manufacturing Liasions (DML) documentation.
    • Nectar’s training and exercise practice.
  • • Highly appreciated by Leadership team for successfully handling “USFDA, EU-GMP & State Drugs/GMP Apporvals” audits at Nectar Lifesciences Ltd., for Good Documentation Practices.
Qualifications

Cape Institute of Technology

Master of Science Biotechnology

2010-2012

-%

Extra-Curricular Interests
• Actively involved in quality assurance and training and mentoring new joiners recruitment process and development of training and induction modules. • Actively involved in knowledge sharing sessions to updated regulatory knowledge of team on recent developments. • Involvement in writing business proposal e.g. RFIs RFPs for business development.
My Story
I currently hold a master’s degree in Biotechnology and have highly adaptable experience in regulatory field of around 5.5 years. I have hands on experience on eCTD document preparation, building structure, compilation, publishing using tools (eCTDXpress, ISI Publisher, ISI toolbox, Lorenz docu-bridge, View Point etc.) and their submission to US-FDA, EMA and ROW via GSG gateways.
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