Profile Details

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USD 30 /hr

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Hire Dr. Sandeep P.

India

USD 30 /hr

Ph.D. in Chemistry with 14 years of experience in regulatory affairs of pharmaceutical products and medical devices

Profile Summary

Ph.D. in Chemistry having a total of 14+ years of experience in the pharmaceutical industry, expertise in the regulatory intelligence of pharmaceutical/Biologics, medical devices, and tobacco regulations.

Subject Matter Expertise

• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Technical Writing

Research User Research, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Data Processing, Data Insights

Product Development Product Validation

Work Experience

Regulatory Intelligence Manager

RegDesk Inc.

April 2020 - Present

Sr. Associate- Global Regulatory Services

IDS Infotech Ltd

June 2018 - April 2020

Sr. Chemist

Mylan Lab. Ltd.

January 2012 - May 2012

Analytical Scientist

Divakar Lab. Ltd.

November 2009 - December 2011

QA/QC Chemist

Cipla Ltd

April 2008 - November 2009

QC Chemist

Aarti Drugs

June 2007 - May 2008

Education

Ph.D. Chemistry (School of Chemical Sciences)

North Maharashtra University

June 2012 - March 2018

PhD (Chemistry)

North Maharashtra University, Jalgaon

May 2012 - March 2018

M.Sc. Chemistry (School of Chemical Sciences)

North Maharashtra University

July 2005 - May 2007

MSC Chemistry

North Maharashtra University, Jalgaon

June 2005 - May 2007

BSc Chemistry

North Maharashtra University, Jalgaon

June 2002 - May 2005

Certifications

• ISO 13485:2016 Quality Management Systems for Medical Devices

  Alison

  https://alison.com/shop

  June 2022 - Present

Publications

JOURNAL ARTICLE

Sandeep Pawar(2017). Synthesis of Ibuprofen intermediate using alcoholic silver nanoparticles and its kinetics: A greener approach towards drug synthesis . Chemical Physics Letters. 671. p. 147--153. Elsevier {BV}

Sandeep Pawar (2016). Gold Nanoparticles Catalyzed Synthesis of Ibuprofen Intermediate in Aqueous Ethanol . Der Pharma Chemica.