Firdos Shera
JP Nagar, Bangalore
Summary
Regulatory Affairs Professional with 11+ years of experience in regulatory dossier submissions and post approval changes primarily for EU market.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Sr. Solution Specialist - Regulatory
ArisGlobal
Bangalore
02.2022 - Current
- RIMS User Training : Train end-users on RIMS functionalities like registrations, submissions, publishing and compliance (xEVMPD, IDMP)
- RIMS Configuration: Configure customer specific business requirements in LifeSphere RIMS
- Business Analysis: Collaborate with stakeholders to gather and document business requirements/processes and translate them into RIMS Configuration
- System updates: Perform testing and validation to ensure data integrity within RIMS platform after system upgrade
- Communication and collaboration with stakeholders from various functions within/ outside company to ensure successful completion of projects
- Knowledge of the overall RA business process, Pharma regulations
- Developed and implemented custom solutions to improve customer satisfaction levels
Senior Executive – EU RA & PV
Momaja Life Sciences (part of PLG Group)
Mumbai
01.2018 - 02.2022
- Preparation and Management of EU Regulatory submission packages - Initial MAA-4, Variations-50+, Renewals-4, MATs-6, Withdrawals-6,
- End to End life-cycle management activities
- Prepare initial gap analysis on the dossier submission requirements and country specific deliverables
- Communication and collaboration with internal / external stakeholders to ensure successful completion of projects
- Perform end-to-end article 57 (xEVMPD) submissions through EVweb – 1200+ AMP submissions
- Ensure compliance with Art 57 regulation to meet upcoming global regulatory requirements for submission of IDMP data based on local implementation guides
- Dossier compilation and publishing in e-CTD formats – 50+ eCTDs
Senior Officer - Regulatory Affairs (EU)
FinOrion Pharma India Pvt. Ltd.
Mumbai
09.2016 - 01.2018
- Responsible for Product Lifecycle Management activity - 13 products
- Prepare EU regulatory submission packages for variations (Type IA/IB/II), Renewals, MATs
- Act as regulatory contact in Indian partner processes when applicable
- Coordinated submission of product applications to various regulatory agencies.
- Performed periodic reviews of existing products to ensure ongoing compliance with applicable laws and regulations.
- Maintained records of all regulatory filings and correspondence.
Officer Regulatory Affairs (EU)
ELC Group (part of PLG Group)
Mumbai
04.2014 - 09.2016
- Preparation and Management of Module 1 documents for the Initial MAA (DCP, MRP and NP)
- Handle Post approval variations - Type IA/IB/II
- Prepared country specific fees chart and dossier submission requirements
- SmPC comparison for EU approved products
- Performed Gap Analysis of the documents received from clients
- Dossier compilation and publishing in e-CTD/NeeS formats
- xEVMPD data submission through Pharma eReport software
Junior Pharma Consultant
P-Con
Baroda
12.2012 - 03.2014
- Supported preparation of documents based on ISO/GMP Guideline
- Supported in the implementation of Quality Management System (QMS) i.e ISO 9001 quality manual / procedures, quality policy/objectives, process flowchart
- Performed review and update of SOPs, daily records
Education
Master's Degree in Pharmacy -
NIPER
01.2011
Bachelor's Degree in Pharmacy, First class -
Saurashtra University
01.2009
Skills
- Regulatory Submission
- Initial MAA (NP, MARP, DCP, CP)
- Product Lifecycle Management
- XEVMPD, IDMP, eCTD
- LifeSphere RIMS
- Regulatory Submissions
- Team Collaboration
- Project Management
Certification
- PG Diploma in Regulatory Affairs (2012)
- Drug Registration and Dossier Preparation (2013)
- PV Training in Oracle Argus Safety Database (2012)
- General Course on Intellectual Property (2010)
Personal Information
- Date of Birth: 02/28/88
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
English, Hindi and Gujarati
Disclaimer
I hereby solemnly declare that all the information provided here is as per the best of my knowledge. If chance is given to me, I assure you that, I will prove myself as an asset to your organization
Timeline
Sr. Solution Specialist - Regulatory
ArisGlobal
02.2022 - Current
Senior Executive – EU RA & PV
Momaja Life Sciences (part of PLG Group)
01.2018 - 02.2022
Senior Officer - Regulatory Affairs (EU)
FinOrion Pharma India Pvt. Ltd.
09.2016 - 01.2018
Officer Regulatory Affairs (EU)
ELC Group (part of PLG Group)
04.2014 - 09.2016
Junior Pharma Consultant
P-Con
12.2012 - 03.2014
Master's Degree in Pharmacy -
NIPER
Bachelor's Degree in Pharmacy, First class -
Saurashtra University
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