Peter Peng PhD

Director of RA @ Biotech

About

1. About 20 years experiences for drug R&D and RA, from project evaluation to dossier submission, to inspection, including NMPA and FDA NDA, IND, ANDA, DMF, and MAH 2. Familiar with regulatory affair 3. Experience for the management R&D projects and team 4. Familiar with license-in 5. Strong ability of communication and creation 6. Experience of the application of patent 7. Fluent English listening, speaking, reading, and writing

Country

China

City

Beijing

Industry

Pharmaceuticals

Skill

Management of drug R&D, CMC, Regulatory Affairs, Product Development, Project Management, Chemistry, Organic Chemistry, Technology Transfer, Manufacturing, Strategic Planning, Pharmaceutical Industry, Drug Development, Microsoft Office, Cross-functional Team Leadership, Medicinal Chemistry, Application of patent

Experience

Director of RA

Biotech

2019-4 - Present · 7 yrs 6 mos

Beijing, China

1. Strategy analysis; gap analysis; review the meeting package and dossier; response to the authority, including FDA and NMPA. 2. In charge of the application for drug manufacturing certificate of MAH. 3. Technical and regulatory support to the drug R&D 4. Responsible to the inspection 5. Management of vendor, including the drug R&D and depot. 6. Regulatory for PMDA (Japan) 7. license-in and license-out for pipeline

VP

Beijing Chengyuanjiaxin Medtech Co., Ltd

2018-3 - 2019-4 · 1 yr 2 mos

Beijing, China

1. Evaluation of new drug project and gap analysis for NMPA. 2. Organizing regulatory of new drugs, from dossier preparation to submission, including IND and IDL 3. Making the annual work plan. 4. Team building. 5. license-in

VP for RD

Deshang Pharmaceutical

2015-4 - 2018-3 · 3 yrs

Beijing

1. Management of the R&D for new drug, from project evaluation to dossier submission 2. Making plan for drug R&D 3. Management BD for new drug 4. Solution to the problem in projects 5. Organizing regulatory of new drugs, from dossier preparation to submission, to inspection 6. Management the application for patent

Director of Medicinal Chemistry

Yabao Pharmaceutical Group

2009-9 - 2015-4 · 5 yrs 8 mos

Beijing

1. Preparation and review dossier for NMPA and FDA 2. Management of the medicinal chemistry lab and team training 3. Management the project from API to drug product as project leader 4. Solution to the problem of project from lead optimization to API process 5. Organizing the inspection 6. Evaluation of new project 7. Management of CRO 8. Application for patent

Director of R&D Lab

FusoGen Pharmaceuticals, Inc

2006-4 - 2009-3 · 3 yrs

Beijing

1. Making new drug plan with general manager 2. Management of the projects in the R&D lab, from in-silicon to LEAD, especially for anti-HIV peptide drug and anti-HBV small molecule drug 3. Preparation and review of new drug dossier 4. Solution for the problem of the project research 5. Management of outsourcing project