Project Manager
Resume:
Abhishek Tyagi
Personal Details
Date of Birth
:
July 28, 1986
Father’s Name
:
Sh. Sumer Chand
Correspondence Address
:
Flat No. 401, 4th Floor, SV Hersha Residency, Plot No. D-10 & D-11, Panchwati Colony, Manikonda, Hyderabad, Telangana – 500089, India
Permanent Address
:
VPO.- Ledi, Tehsil-Chhachhrauli, Yamunanagar, Haryana – 135103
Mobile Number
:
+91-989*******, +91-756*******
:
****************@*****.***
Passport Number
:
L8531722
Professional Profile
A highly adaptable regulatory professional with experience of around 5 years (in Regulatory Affairs & Regulatory Operations). Hands on experience on eCTD document preparation, building structure, compilation, publishing using tools (eCTD Xpress, ISI Publisher, ISI toolbox, Lorenz docubridge, View Point etc.). Preparation and submission of regulatory dossiers in EU-EMA, US-FDA, Swiss-Medic and ROW on a vast range of therapeutic areas. Experience of leading a team and project management with successful management of multiple projects. Excellent written/ spoken communication skills.
Life-Science Applications
eCTDxpress, ISI publisher, Lorenz docubridge, Pharmaready, ISI Toolbox, PDF Utilities, GDMS (Documentum), RADARS, Lorenz evalidator, Belgium evalidator, Extedo-Globalvalidator,View-Point & Rosetta Phoenix.
Submissions Handled:
US (eCTD): Original Applications, Labeling Amendments, Protocol Amendments, Information Amendments, General Correspondence & INDs Safety Submisison (7-days, 15-days Initial & 15-days Follow-up), Annual Reports, DSUR’s and CSR publishing and their dispatches via GSG gateways.
EU (eCTD - CP): Variations (Type- IA & Type –IB & Type-II), Supplemental Info, FUMs, PSUR’s and their dispatches via GSG gateways.
EU (NeeS): Original Submissions, Renewals, Answer to Health Authority Questions, Supplemental Info, Variations (Type- IA & Type –IB & Type-II).
EU & ROW (Paper format): CTA original, CTA Amendments, IMPD Original, IMPD Amendments, IB amendments & Answer to Health Authority Questions.
Swiss-Medic: eCTD & NeeS Submissions.
Professional Experience
Organization 1
Freyr Software Solutions, Hyderabad, India
Designation
Assistant Manager - Regulatory Operations (eCTD, NeeS & Paper publishing)
Duration
April 2014 - Present
Client
Novartis Pharma Limited (onsite project)
Project Title
Regulatory Compilation (eCTD publishing)
Team Size
14
Description:
Freyr is a full-service Global Regulatory Solutions and Services Company and a specialist provider of Consulting, Operations & Technology Services.
Roles and Responsibilities:
Organization & Preaparation of metadata form, Submission request form & Tracking tool for Regulatory US, SwissMedic and CP eCTD submission.
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 & CESP) via GSG gateway.
Original submissions and Lifecycle maintenance of dossier.
Create and verify bookmark structure and hyperlinks to ensure submission readiness.
Archival submissions.
Assist to client for process optimization.
Assist to client for resource management & new reource requirements.
Leading the team of 06 members handling submission publishing.
Collection of metrics – Timelines, Prodcutivity and Quality for weekly and monthly meetings.
Computer based trainings and exercise practice conducted by client.
Organization 2
Accenture (Accelerated R&D and Regulatory services), Bangalore, India
Designation
Regulatory Analyst - Electronic submission specialist
Duration
May 2013 – April 2014
Client
AstraZeneca, BMS, GSK, Sankyo, Alkeremes, Allergan, Pharmacyclics, and Vascular Therapies etc.
Project Title
Publishing, Document QC and Final document QC
Team Size
69
Description:
Accenture Accelerated R&D and Regulatory services – a next generation solution that helps Lifesciences companies in the Regulatory services, Clinical services & Pharmacovigilance services to increase productivity and improve quality, driving more efficient compliance.
Roles and Responsibilities:
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.
Organization 3
Take Solutions Global LLP, Chennai, India
Designation
Regulatory Associate - Regulatory Publishing (eCTD/Nees/Paper).
Duration
July 2012- April 2013
Client
Pfizer, USA
Project Title
eCTD and NeeS publishing, quality check & archival submission for US, Europe and ROW markets.
Team Size
70
Description:
TAKE is a global technology solutions and service provider, with significant focus across two principal business areas – Life Sciences and Supply Chain Management. The business segments of the Company include Software Products & Consultancy Services, E-Business Solutions and Others. Pharma-Ready is the major product of TAKE in Life Science which is a single source of clinical data services, regulatory compliance and drug safety systems.
Roles and Responsibilities:
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.
Organization 4
Nectar Lifesciences Limited (USFDA, CEP & EU-GMP Approved facility), Chandigarh, India
Designation
Senior Chemist (Regulatory Affairs)
Duration
Nov 2010 – June 2012
Client
Nectar Lifesciences Limited.
Project Title
Regulatory Compilation (eCTD publishing & Submissions)
Team Size
5
Description:
Nectar Lifesciences Limited is an integrated pharmaceutical company in India that manufactures generic products for EU and USA. The company is the largest manufacturer of Cefuroxime Axetil API and Cefixime API in the world and manufactures 25% of menthol (raw) of the world. It also manufactures oral and sterile active pharmaceutical ingredients, finished dosages and phytochemicals.
Project sope included authoring, review & compilation of regulatory dossiers of generic APIs and eCTD publishing (using Docubridge).
Roles and Responsibilities:
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.
Additional Responsibilities:
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, RFP for business development.
Awards & Recognition:
Highly appreciated by Leadership team for successfully handling “USFDA, EU-GMP & State Drugs/GMP Apporvals” audits at Nectar Lifesciences Ltd., for Good Documentation Practices.
Awarded as Best Publisher of the Year 2012- 2013 by Pfizer for maximum numbers of submission with highest Quality.
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).
Timely appreciated by the Client, Project manager and Team Lead for taking various initiatives to improve project process and quality of deliverables.
Education & Qualifications
Examination
Year
University / Board
Percentage
M.Sc. Bio-Technology
2010
Bangalore University
66 %
B.Sc. Bio-Technology
2008
Kurukshetra University
60 %
Personal Strengths
Excellent communication skills with core competency on Pharma regulatory compliance and services.
Capability of executing challenging assignments with right blend of intelligence, diligence and patience
Flexibility to learn any new technology
Excellent team player
Languages: - Proficient in English, Hindi and Punjabi.
Declaration:
I hereby declare that the above-furnished details are true and correct to the best of my knowledge and belief.
Date: (Abhishek Tyagi)
Place:
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