- Regulatory CMC professional, Regulatory Affairs Certified (RAC), PhD in chemistry; regulatory affairs CMC in cross-functional development teams for FIH, late stage, and life-cycle management projects to develop both small molecules and biologics; experience in successful global filing and approval of marketing applications. - Hands-on experience in authoring and editing regulatory CMC dossiers: o Investigational filing such as IB CMC input, IND, IMPD, CTAs, Amendment, Annual report, FDA/EMA/PMDA meeting briefing document (BD), and global health authority (HA) query response. o Marketing applications such as (Modules 2.3 and 3 eCTD) NDA, MAA, JNDA, and ROW filings. o Biologics: oncology - monoclonal antibody. - In-depth knowledge and extensive experience with interpretation and application of CMC related ICH, FDA, EU, Japan, and China regulations. - Highly organized with strong communication, interpersonal, and negotiation skills; excellent in managing multiple and varied teaks in a fast-moving environment. - Excellent software skills in PRISM-CARA, Documentum, ChemBioDraw, SciFinder, Microsoft Office, and Outlook etc., to support authoring, reviewing, and publishing tasks. - Multilingual skills (speaking, writing): Japanese and Chinese.

Associate Director, Regulatory Affairs CMC @ My responsibility includes - Represent regulatory CMC in cross-functional teams at development stages from FIH to marketing application and lifecycle management.. - Provide interpretation of global regulatory CMC guidelines to cross-functional teams to ensure regulatory compliance. - Author and critically review eCTD CMC submissions. - From April 2014 to Present (1 year 9 months) Senior Manager, CMC Documentation @ - Represent regulatory CMC documentation in cross-functional teams (over 20 new molecular entities or drug products in 8 years) at development stages from FIH to marketing application and lifecycle management. - Lead planning and authoring process of CMC dossiers in support of global eCTD submission - secure source data and document, coordinate authoring activities, global team review/consensus meeting, and management approval. - Provide interpretation of global regulatory CMC guidelines to cross-functional teams to ensure regulatory compliance. - Lead specification development process - coordinate specification meeting in project teams, author spec proposal data packages, propose specifications/revisions and Global Test Standards to Specification Committee for drug substance, intermediate, regulatory starting materials, etc, and work with project teams and the Committee to win specification approval. - Evaluate development changes and provide impact assessment on regulatory activities. - CMC lead author and editor for Dapagliflozin (diabetes drug approved in EU, 2012) marketing application - Authored all CMC submissions from Phase 2a through NDA/MAA/PMDA and life-cycle management (8 years): IB CMC updates, IMPD, CTAs, IND amendments, annual reports, Modules 2.3/3 drug substance eCTD sections for marketing applications, global HA query responses, FDA EOP2 and Type C meeting BDs, etc. - Authored ten initial IND/CTAs to support launch of FIH studies globally. From 2005 to March 2014 (9 years) Senior Principal Scientist @ - Pre-clinical development of AP-158: o Prepared CMC documents. o Managed API process development, formulation development, and technology transfer to CROs. o Monitored CROs for stability study, toxicology study, and cGMP production of API. - Performed rational design, synthesis, lead optimization and evaluation of antibacterial agents. - Coordinated process scale-up work, bioavailability study and in vitro/vivo testing effort. - Conducted prior art search, prepared patent filings and assisted in patent prosecution. - Supervised associate scientists. From 1999 to 2005 (6 years) Chemistry Group Leader @ - Oversaw a contract drug discovery project funded by the Division of Antiinfectious, Parke Davis Research. - Supervised a group of eight chemists performing rational design and optimization of antibacterial leads targeting Gyrase A, Topo II, Topo IV, Fab I and histidine kinase. - Proposed optimization plans to bid new contracts from Parke-Davis. From 1995 to 1999 (4 years) Research Associate @ - Designed, synthesized, and biochemically evaluated DNA-binding anticancer drugs mimicking bleomycin and distamycin; co-authored 16 research papers and 2 review articles about anticancer drugs. From 1992 to 1995 (3 years)

Doctor of Philosophy (Ph.D.), Organic Chemistry @ University of Tsukuba Liren Huang is skilled in: Regulatory Affairs, Drug Discovery, IND, Cross-functional Team Leadership, Chemistry, eCTD, GMP, Clinical Development, Regulatory Submissions, Oncology, CRO, Technology Transfer, FDA, Pharmaceutical Industry, Formulation