Surbhi Gupta Email & Phone Number | I was responsible for medical writing and coordinating preclinical and integrated clinical study reports along with preparation of patent applications. Responsible for MDR and ISO 13485 compliance. I have working knowledge of ICH,l cGMP, TGA, ISO 13485, CFR 820, LIMS, DMF (EU and US), HSA, AVA, REACH, SVHC, SAP, ISO 9001, CDSCO, 510(k), MDR, ASEAN Cosmetic directive and labelling requirements for different health ministries. Prepare research and regulatory strategies for product development and registration. Markets dealt are US, Australia, ASEAN and EU. Responsible for reviewing clinical development plan and prepare strategies for a clinical trial. I have expertise in developing and compiling CMC related documents for submission to clients for various drug regulatory authorities ensuring compliance of operations with governing regulatory agencies. I have coordinated and interacted with R&D scientists on a daily basis to discuss and comprehend the development process of the drug in preparing relevant reports. Possess strong project management skills. I was involved in compiling and reviewing Analytical Development Reports (ADR’s) and Stability Study Reports (SSR’s) along with implementing the use of consistent, efficient and quality processes to meet client timelines and deliverables according to regulatory requirements. I have dealt with dossiers (ACTD and CTD) filing for US, EU, AU and ROW for human, cosmetics, OTC, vet and medical devices. I am well versed with FDA Liasioning functions like applying product permission, COPP and test licences, export orders, invoices and free sale certificate. I was a regulatory trainer in CRO where I used to guide diploma students on FDA and regulatory requirements and groomed them for interview and presentation skills. My M-Pharm project work was amongst the top 5 projects all over India recognised in the R.V. Patel best innovative thesis award. My AIR was 2121 in GPAT. I have 3 research articles and 1 review article in prestigious journals.

Surbhi Gupta

I was responsible for medical writing and coordinating preclinical and integrated clinical study re...
Pune, Maharashtra, India

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Surbhi Gupta’s Email surbhi.gupta@aoi.sg

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Surbhi Gupta’s Location Pune, Maharashtra, India

Surbhi Gupta’s Current Industry

Surbhi Gupta’s Prior Industry Clinuvel Pharmaceuticals | Crest Springernature Technology And Publishing Solutions | Covance | Sava Healthcare

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Work Experience

Advanced Ophthalmic Innovations

Senior Manager Clinical and Regulatory Affairs

Present

Clinuvel Pharmaceuticals

Scientific Affairs Project Manager

2019-05-01T00:00:00.000Z - 2020-09-01T00:00:00.000Z

Crest Springernature Technology And Publishing Solutions

Scientific And Medical Writer

2018-09-01T00:00:00.000Z - 2019-01-01T00:00:00.000Z

Covance

Regulatory Affairs Specialist

2015-10-01T00:00:00.000Z - 2018-08-01T00:00:00.000Z

Sava Healthcare

Officer Drug Regulatory Affairs

2013-11-01T00:00:00.000Z - 2015-10-01T00:00:00.000Z

Skills

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Languages

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FAQ About Surbhi Gupta

Surbhi Gupta is located at
Pune, Maharashtra, India

Surbhi Gupta is a I was responsible for medical writing and coordinating preclinical and integrated clinical study reports along with preparation of patent applications. Responsible for MDR and ISO 13485 compliance. I have working knowledge of ICH,l cGMP, TGA, ISO 13485, CFR 820, LIMS, DMF (EU and US), HSA, AVA, REACH, SVHC, SAP, ISO 9001, CDSCO, 510(k), MDR, ASEAN Cosmetic directive and labelling requirements for different health ministries. Prepare research and regulatory strategies for product development and registration. Markets dealt are US, Australia, ASEAN and EU. Responsible for reviewing clinical development plan and prepare strategies for a clinical trial. I have expertise in developing and compiling CMC related documents for submission to clients for various drug regulatory authorities ensuring compliance of operations with governing regulatory agencies. I have coordinated and interacted with R&D scientists on a daily basis to discuss and comprehend the development process of the drug in preparing relevant reports. Possess strong project management skills. I was involved in compiling and reviewing Analytical Development Reports (ADR’s) and Stability Study Reports (SSR’s) along with implementing the use of consistent, efficient and quality processes to meet client timelines and deliverables according to regulatory requirements. I have dealt with dossiers (ACTD and CTD) filing for US, EU, AU and ROW for human, cosmetics, OTC, vet and medical devices. I am well versed with FDA Liasioning functions like applying product permission, COPP and test licences, export orders, invoices and free sale certificate. I was a regulatory trainer in CRO where I used to guide diploma students on FDA and regulatory requirements and groomed them for interview and presentation skills. My M-Pharm project work was amongst the top 5 projects all over India recognised in the R.V. Patel best innovative thesis award. My AIR was 2121 in GPAT. I have 3 research articles and 1 review article in prestigious journals.

Surbhi Gupta currently works in the

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Surbhi Gupta has prior
experience in the following industries:
Clinuvel Pharmaceuticals | Crest Springernature Technology And Publishing Solutions | Covance | Sava Healthcare

Surbhi Gupta has the following professional experience:
Advanced Ophthalmic Innovations | Clinuvel Pharmaceuticals | Crest Springernature Technology And Publishing Solutions | Covance | Sava Healthcare