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Namita Nair
Lead Executive Regulatory Affairs
Mumbai
Summary
Regulatory Affairs professional with 6.5 years of experience in global pharmaceutical markets including US, Canada, EU, APAC, LATAM, and ANZ. Proven success in lifecycle management, regulatory submissions, Health Authority responses, and portfolio integration. Strong track record in handling variations, labeling, and change control assessments with on-time, audit-ready execution.
Overview
7
7
years of professional experience
7
7
years of post-secondary education
4
4
Languages
Work History
Lead Executive, Regulatory Affairs
Apotex Research Pvt Ltd
10.2024 - Current
- Lead end-to-end lifecycle management for 100+ marketed products across US, Canada, Australia, New Zealand, Latin America, APAC, CAR markets.
- Led regulatory execution for 65 Searchlight products (Canada) including NHPs, devices, and liquid/semi-solid forms via Level I/III submissions.
- Coordinated HA responses and labeling updates; supported global SOP harmonization.
- Conducted change control assessments and tracked HA guideline changes for US, Canada, Australia, New Zealand, Latin America, APAC, CAR and EU.
- Acted as reviewer for Level III submissions in Canada, Notification submissions in LATAM/APAC/CAR, and regulatory change controls.
Executive, Regulatory Affairs
Apotex Research Pvt Ltd
01.2022 - 10.2024
- Oversaw submissions for US, Canada, and APAC markets.
- Submitted 60+ variations and 100+ renewals/annual reports with 100% on-time delivery.
- Supported CMC supplements, labeling updates, and audits.
- Managed change control evaluations and monitored HA updates across regions.
Executive, Regulatory Affairs
Lupin Limited
10.2018 - 12.2021
- Filed 15+ PAS, CBE-30, and CBE-0 submissions for US market.
- Responded to FDA deficiencies and coordinated site registrations.
- Supported GMP audits, reviewed commercial artwork, and tracked FDA guidance.
Education
M. Pharm - Pharmaceutics
SNDT University
01.2016 - 01.2018
B. Pharm - undefined
AISSMS College of Pharmacy
01.2011 - 01.2016
Skills
- Lifecycle Management
- ScienceDirect
- Adobe Pro
- Educe-eCTD
- GLAMS
- Trackwise QMS/RIMS
- Veeva Vault
- Cross-functional Collaboration
- M&A Due Diligence
- Regulatory Intelligence
- CTD/eCTD Dossiers
- Labeling & Artwork Compliance
- Change Control Assessment
- Renewals & Deficiency Responses
- Variation Filings (PAS/CBE-30/CBE-0, Level I & III, CAT-3, CMN)
- Health Authority Liaison
- Global Regulatory Submissions
- Lifecycle Management
Websites
Awards
- GRA Award, Apotex, 2023
- Spot Awards, Lupin
- 2019
- 2020
Interests
Travelling
Volunteer work
Timeline
Lead Executive, Regulatory Affairs
Apotex Research Pvt Ltd
10.2024 - Current
Executive, Regulatory Affairs
Apotex Research Pvt Ltd
01.2022 - 10.2024
Executive, Regulatory Affairs
Lupin Limited
10.2018 - 12.2021
M. Pharm - Pharmaceutics
SNDT University
01.2016 - 01.2018
B. Pharm - undefined
AISSMS College of Pharmacy
01.2011 - 01.2016
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