Randall Lis Email & Phone Number

Harleysville, Pa, Us

•Global CMC Regulatory Affairs Professional•Expertise in Global CMC Strategy including Common Technical Document (CTD) format/writing/detailed reviewing/approval of CMC submissions•Provide CMC Regulatory Affairs Consulting Activities•Experienced in preparation/review/approval of global clinical Investigational New Drug applications (CMC sections)•Experienced in preparation/review/approval of new Market Product Application dossiers (CMC sections)•Experienced in all CMC Labeling requirements for INDs/NDAs•Strong Knowledge of ICH Guidelines (CMC)•Very Strong Scientific Background (Ph.D. in organic chemistry)•Decades of Managerial Experience•Interaction with multiple 3rd Party Manufacturers •Broad background in the drug development process•Have consulted for the following companies; Shire, Quantic, Vascular Therapies Inc., SPI Pharma, Lexicon Pharmaceuticals, Taiho Oncology Inc., Serenity Pharmaceuticals, LLC, Mitsubishi Tanabe Pharma Inc., DSInpharmatics LLC, SK Life Sciences, Inc., GlycoMimetics, Inc., Avanir Pharmaceuticals, Inc., Cascadian Therapeutics Inc., Aratana Therapeutics, Inc., Puma Biotechnology, Inc., Neos Therapeutics Inc., Celator (Jazz) Pharmaceuticals, Kura Oncology Inc., and NewLink Genetics Corp..•Experience with a drug-device market application for Europe and excipient, API and drug product intermediate requirements for global customer needs.

•Reviewing and approval of new Market Product Application dossiers in Common Technical Document (CTD) format, clinical Investigational New Drug Applications (INDs, CTAs and IMPDs) and global Board of Health CMC responses •Interaction with several groups within the organization, such as, Regulatory Affairs, International Quality Operations (QO), Technical Services (TS), Domestic QO and TS and Technical Operations & Product Supply (TO&PS)•Interaction with 3rd Party Manufacturers •Responsible for the CMC sections of Package Inserts, Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL) and Investigator’s Brochures •Involved with global CMC regulatory strategy•Group responsibilities were to provide CMC documentation for all Clinical Trial Material submissions globally and Wyeth new Market Product Applications•Directly supervised five individuals at two sites (Collegeville, PA and Pearl River, NY, group total of up to 15 individuals)

Ph.D., Organic Chemistry

Ba (High Distinction), Chemistry