Rahul R P
Toronto
Summary
- Over 9 years of professional experience in various areas of clinical publishing, and regulatory operations in the Pharmaceutical and Life science industry.
- Worked as a Team Supervisor at Parexel and lead 12 people in completing the Data Migration project successfully.
- Expertise in creating global regulatory submissions/ in eCTD format for different application types such as IND, NDA/NDS, SNDS, ANDA, BLA, DMF, MAA, AdProm (Advertising Promotional Professional and Consumer, Pre-Clearance) to FDA, and Health Canada.
- Experienced in Next Docs, QUMAS, SharePoint, Liquent Smart Desk product, ISI toolbox and experienced in Document Preparation (Bookmarking and Hyperlinking) on different modules from M1-M5 and performing QC tasks.
- Coordinated the submission of Safety Reports (DSUR, PBRER, PSURs), Annual Reports and ensures timely submissions with original and lifecycle regulatory submissions in eCTD format including technical review of critical components for accuracy, compliance with Health Authority requirements and internal standards.
- Understanding of change control documentation, quality systems, and documents.
- Experienced in working with CSR, DSUR, PSUR, PBRER, Annual Reports, Clinical Trial registrations, and Ensuring compliance with clinical trial registry regulations (design registration and updates) - CT. Gov & ENCEPP
- Working Knowledge and experience for US FDA guidance and ICH guidelines along with Electronic Gateway Submissions.
- Experienced in registering clinical trial information on clinical trial registries (e.g. Clinicaltrial.gov, ENCePP) at the time of working with Novartis and external agency's requirements.
- Quick Learner, the ability to learn new skills and software products that are available in the market, and can work individually and/or in a team with minimum supervision.
Overview
13
13
years of professional experience
Work History
Sr Regulatory Operations Consultant
Nascent Pharma Consulting
06.2021 - Current
Sr. Regulatory Operations Consultant
Aimmune Therapeutics
11.2018 - 12.2021
Sr. Regulatory Publishing Consultant
Mallinckrodt Inc.
02.2018 - 05.2018
Senior Regulatory Operations Consultant (Remote)
PAREXEL
07.2017 - 12.2017
Regulatory Operations Consultant
Portola Pharmaceuticals Inc.
02.2016 - 12.2016
Regulatory Operations Consultant
Novartis
02.2013 - 04.2014
Junior Regulatory Associate
LIQUENT- A PAREXEL Company
02.2012 - 08.2013
Education
Master of Business Administration - Strategic Management
University of the Cumberlands
01.2019
Master of Science - Health Care Management
University of New Orleans
05.2010
Bachelor of Engineering - Biomedical Engineering
JNTU Affiliated
05.2007
Skills
- Pre-Publishing tools
- Publishing Tools
- Validating Tools
- Gateways
- Process/Model Tools
- EDMS
- Liquent Smart Desk
- ISI Toolbox for PDF plugins
- Liquent Insight Manager
- Lorenz DocuBridge
- EXTEDO eCTD Manager
- ECTDXpress
- Global Validator
- EURS Validator
- Lorenz eValidator
- Insight Validator
- FDA ESG
- CESG
- Adobe Acrobat
- MS Office Suite 365
- MS Visio
- MS Project
- TVT
- SharePoint
- Veeva Vault
- Qumas
- Atlas Management System
- First Doc
- Next Doc
- Pluto
Relevant Work Titles
- Sr. Regulatory Operations Consultant, Aimmune Therapeutics (Ray IT Solutions), 11/18, 12/18
- Sr. Regulatory Publishing Consultant, Mallinckrodt Inc., Saint Louis, MO, USA, 02/18, 05/18
- Sr. Regulatory Operations Consultant (Remote), Portola Pharmaceuticals Inc. (Contract), South SFO, CA, USA, 07/17, 12/17
- Regulatory Operations Consultant, Novartis, Vaccines and Diagnostics, Hyderabad, India, 02/16, 12/16
- Clinical Publishing Associate and Trial Administrator, LIQUENT- A PAREXEL Company, Bangalore, India, 09/13, 04/14
- Junior Regulatory Associate, 02/12, 08/13
Relevant Pharmaceutical Experience
Paper, NeeS, eCTD, National (Country specific) publishing activities by using different electronic tools, ensuring their dispatch via FedEx/ESG or CESG/ AS2 gateways., Published CTA/IND Variations, Renewals, Supplemental submissions, Q&A packages, ANDA's, DSUR, PSUR packages, and largest NDA/NDS/MAA submissions to European markets, United States, Canada, and the Rest of the World in eCTD/ non-eCTD and hybrid formats., Expertise with country-specific regulatory publishing requirements. (US, CA, and EU)., Insight Advanced Publisher (effective use, training, and certification, identifying the challenges, troubleshooting, and worked closely with the product development team at PARAXEL for tool Optimization., Defining and optimizing the standards for building high-quality regulatory documents by preparing PDF checklists, document quality checklists, working guidelines, templates, and other agency updates., Liquent Smart Desk product, ISI (DXC) Toolbox for PDF plugins., Liquent Insight Manager (5.1 and 6.1), Lorenz DocuBridge, EXTEDO eCTD Manager, eCTDXpress for USA, EU, and Canada, Global and EURS Validator, Lorenz eValidator, Insight Validator, FDA ESG, CESG, Adobe Acrobat, MS Office Suite 365, MS Visio, MS Project, TVT (Text Verification Tool), SharePoint, Veeva Vault, Qumas, Atlas Management System, First Doc, Next Doc, Pluto (Lundbeck)
Timeline
Sr Regulatory Operations Consultant
Nascent Pharma Consulting
06.2021 - Current
Sr. Regulatory Operations Consultant
Aimmune Therapeutics
11.2018 - 12.2021
Sr. Regulatory Publishing Consultant
Mallinckrodt Inc.
02.2018 - 05.2018
Senior Regulatory Operations Consultant (Remote)
PAREXEL
07.2017 - 12.2017
Regulatory Operations Consultant
Portola Pharmaceuticals Inc.
02.2016 - 12.2016
Regulatory Operations Consultant
Novartis
02.2013 - 04.2014
Junior Regulatory Associate
LIQUENT- A PAREXEL Company
02.2012 - 08.2013
Master of Science - Health Care Management
University of New Orleans
Bachelor of Engineering - Biomedical Engineering
JNTU Affiliated
Master of Business Administration - Strategic Management
University of the Cumberlands
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