Harun Sinha Email & Phone Number | 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

Providing Regulatory CMC assistance to biopharma industry and clients of various needs. Skilled in l...
New York, New York, United States

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Harun Sinha’s Email hsinha@ascentagepharma.com

Harun Sinha’s Phone Numbers

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Harun Sinha’s Location New York, New York, United States

Harun Sinha’s Current Industry Spark Cmc Consulting

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Work Experience

Spark Cmc Consulting

Principal Consultant - Regulatory CMC

2019-03-01 00:00:00 - Present

Ascentage Pharma

Associate Director, Regulatory CMC

2018-11-01 00:00:00 - 2019-03-01 00:00:00

Ppd

Associate Director

2016-06-01 00:00:00 - 2018-11-01 00:00:00

Cardinal Health

Manager, CMC (Specialty Solutions)

2015-05-01 00:00:00 - 2016-06-01 00:00:00

Self Employed

Independent Consultant, Regulatory Affairs

2013-07-01 00:00:00 - 2014-09-01 00:00:00

Pharmalink Consulting

Senior Manager - Regulatory Affairs

2011-11-01 00:00:00 - 2013-07-01 00:00:00

Glaxosmithkline

Regulatory Affairs Associate

2008-10-01 00:00:00 - 2010-07-01 00:00:00

Alphapharm

Regulatory Affairs Associate

2006-05-01 00:00:00 - 2008-01-01 00:00:00

Astrazeneca

Validation Engineer

2004-01-01 00:00:00 - 2006-04-01 00:00:00

Pfizer

Validation Engineer

2002-01-01 00:00:00 - 2004-01-01 00:00:00

Leiner Health Products Sc Usa

Validation Specialist I

1999-01-01 00:00:00 - 2001-03-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

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.

Harun Sinha currently works in the Spark Cmc Consulting |

No Languages Available

Harun Sinha has prior
experience in the following industries:
Ascentage Pharma | Ppd | Cardinal Health | Self Employed | 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 | Self Employed | Pharmalink Consulting | Glaxosmithkline | Alphapharm | Astrazeneca | Pfizer | Leiner Health Products Sc Usa