Harun Sinha
Providing Regulatory CMC assistance to biopharma industry and clients of various needs. Skilled in large CMC compliance/conformance projects... | New York, New York, United States
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Harun Sinha’s Emails hs****@as****.com
Harun Sinha’s Phone Numbers No phone number available.
Social Media
Harun Sinha’s Location New York, New York, United States
Harun Sinha’s Expertise Providing Regulatory CMC assistance to biopharma industry and clients of various needs. Skilled in large CMC compliance/conformance projects in managing marketed/established products portfolio as well as assisting clients with their pre-approval activities (INDs, CTAs, etc.) including strategy and phase appropriate dossier preparation. Specialties: cGMP, ISO, FDA / EU / TGA regulations, DMF & CEP, eCTD / CTD, CMC, IND, CTA, ANDA, NDA, MAA, BLA, CPP, OTC, Rx and Medical Device.
Harun Sinha’s Current Industry Spark Cmc Consulting
Harun
Sinha’s Prior Industry
Leiner Health Products Sc Usa
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Pfizer
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Astrazeneca
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Alphapharm
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Glaxosmithkline
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Pharmalink Consulting
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Self Employed
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Cardinal Health
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Ppd
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Ascentage Pharma
|
Spark Cmc Consulting
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Work Experience
Spark Cmc Consulting
Principal Consultant - Regulatory CMC
Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Ascentage Pharma
Associate Director, Regulatory CMC
Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Ppd
Associate Director
Wed Jun 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Cardinal Health
Manager, CMC (Specialty Solutions)
Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jun 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Cardinal Health
Sr. Scientific Consultant, CMC
Mon Sep 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Self Employed
Independent Consultant, Regulatory Affairs
Mon Jul 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Sep 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Pharmalink Consulting
Senior Manager - Regulatory Affairs
Tue Nov 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jul 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Pharmalink Consulting
Regulatory Affairs Consultant
Thu Jul 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Nov 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Glaxosmithkline
Regulatory Affairs Associate
Wed Oct 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jul 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Alphapharm
Regulatory Affairs Associate
Mon May 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Astrazeneca
Validation Engineer
Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Apr 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Pfizer
Validation Engineer
Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)
Leiner Health Products Sc Usa
Validation Specialist I
Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Mar 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Harun Sinha Email Addresses
FAQ About Harun Sinha
-
Harun Sinha is located at
New York, New York, United States -
Harun Sinha is a
Providing Regulatory CMC assistance to biopharma industry and clients of various needs. Skilled in large CMC compliance/conformance projects in managing marketed/established products portfolio as well as assisting clients with their pre-approval activities (INDs, CTAs, etc.) including strategy and phase appropriate dossier preparation. Specialties: cGMP, ISO, FDA / EU / TGA regulations, DMF & CEP, eCTD / CTD, CMC, IND, CTA, ANDA, NDA, MAA, BLA, CPP, OTC, Rx and Medical Device. Spark Cmc Consulting -
Harun Sinha currently works in the
Spark Cmc Consulting -
Harun Sinha specializes in
Providing Regulatory CMC assistance to biopharma industry and clients of various needs. Skilled in large CMC compliance/conformance projects in managing marketed/established products portfolio as well as assisting clients with their pre-approval activities (INDs, CTAs, etc.) including strategy and phase appropriate dossier preparation. Specialties: cGMP, ISO, FDA / EU / TGA regulations, DMF & CEP, eCTD / CTD, CMC, IND, CTA, ANDA, NDA, MAA, BLA, CPP, OTC, Rx and Medical Device. -
Harun Sinha speaks the following languages:
No languages available. -
Harun Sinha has prior experience in the following industries:
Ascentage Pharma , Ppd , Cardinal Health , Cardinal Health , Self Employed , Pharmalink Consulting , Pharmalink Consulting , Glaxosmithkline , Alphapharm , Astrazeneca , Pfizer , Leiner Health Products Sc Usa -
Harun Sinha has the following professional experience:
Spark Cmc Consulting , Ascentage Pharma , Ppd , Cardinal Health , Cardinal Health , Self Employed , Pharmalink Consulting , Pharmalink Consulting , Glaxosmithkline , Alphapharm , Astrazeneca , Pfizer , Leiner Health Products Sc Usa . -
You can view Harun Sinha’s
LinkedIn profile at LinkedIn URL. -
Harun Sinha’s work email addresses are
[email protected] . -
Harun Sinha works at
Spark Cmc Consulting
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