Randall Lis

Global R&D Regulatory Leader with extensive work in Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs submissions bringing a multitude of products to market. This includes several >$500 million drug product such as Protonix, Premarin, Effexor and Zosyn. Successfully lead numerous global clinical Investigational New Drug applications.

Built and developed diverse, productive teams across geographies. Clear, effective communicator with a focus on resolving issues and achieving business objectives.

President - REL CMC Consulting LLC - Garnet Valley, PA and Las Vegas, NV

(2012-01)

Provided Global CMC Regulatory Affairs consulting activities to various companies such as Shire, The Quantic Group, Ltd., Vascular Therapies Inc., SPI Pharma, Lexicon Pharmaceuticals, Taiho Oncology, Inc., Serenity Pharmaceuticals, LLC., Mitsubishi Tanabe Pharma Inc., DSInpharmatics LLC, SK Life Science, Inc., GlycoMimetics, Inc., Cascadian Therapeutics, Aratana Therapeutics, Inc., Puma Biotechnology, Inc., Neos Therapeutics Inc., Celator (Jazz) Pharmaceuticals, ArQule, Inc., Fulcrum Therapeutics, Madrigal Pharmaceuticals, Syros Pharmaceuticals Inc., Global Harvest Pharma, NewLink Genetics Corp./Lumos Pharma, Karuna Therapeutics, Kura Oncology, Origin Biosciences, Syndax Pharmaceuticals, Inc., KBP Biosciences, Enanta Pharmaceuticals, Silverback Therapeutics, QED Therapeutics, Cyclacel Pharmaceuticals, Urovant Sciences, Zogenix, Viracta Therapeutics, Inc., Fusion Pharmaceuticals, Inc., Knopp Biosciences (Areteia), LLC, Ayala Pharmaceuticals, Fore Biotherapeutics, Ceva Animal Health, Parion Sciences, Inc., Landos Biopharma, Inc., Cidara Therapeutics, Salamandra LLC, Connect Life Sciences, LLC, and AiCuris GmbH.

Senior Director, GCMC Regulatory Affairs - Pfizer (Wyeth) R&D - Collegeville, PA

(2006-01 - 2011-12)

Led 15 staff at two sites (Collegeville, PA and Pearl River, NY) and provided all CMC regulatory submissions for new Market Product and global clinical Investigational New Drug applications.

• Reviewed and approved new Market Product application dossiers in CTD format, clinical Investigational New Drug applications (INDs, CTAs and IMPDs) and global Board of Health CMC responses.
• Served as a liaison between several groups within the organization, such as, Regulatory Affairs, International and Domestic Quality Operations, Tech. Services and Tech. Operations & Product Supply.
• Interacted with 3rd Party Manufacturers in preparing Market Product applications.
• Responsible for the CMC sections of Package Inserts, Summary of Product Characteristics, Patient Information Leaflets and Investigator's Brochures.
• Group responsibilities were to provide all CMC documentation for all clinical trial material submissions globally and new Market Product applications.
• Wyeth Research – Team of the Year Award, 2006 (Twice, Relistor Development Team and Japan CMC Integration Team) and 2008 (Protonix Granules Pediatric).
• Volunteered for a Special Assignment in the Market Product Conformance group (2010-12/2011).

Director, CMC Regulatory Submissions - Wyeth R&D - Collegeville and Radnor, PA

(2003-01 - 2006-12)

Managed 8 staff at two sites (Collegeville, PA and Pearl River, NY). Group provided all CMC regulatory submissions for new Market Product and global clinical Investigational New Drug applications.

• Reviewed and approved new Market Product application dossiers, clinical Investigational New Drug applications and global Board of Health CMC responses.
• Contributed to global CMC regulatory strategy for Market Product Application.
• Served as a liaison between several groups within the organization.
• Responsible for the CMC sections of Package Inserts, Summary of Product Characteristics, Patient Information Leaflets and Investigator's Brochures.
• Wyeth Research – Team of the Year Award, 2004 (Tygacil CMC Development) and 2005 (European Product Conformance).

Associate Director, CMC Regulatory Submissions - Wyeth R&D - Collegeville and Radnor, PA

(2000-01 - 2003-12)

Development Regulatory Affairs Specialist, Developmental Affairs - Wyeth R&D - Collegeville/Radnor, PA

(1998-01 - 2000-12)

Managed 3 staff in Collegeville/Radnor, PA. Group provided all CMC regulatory submissions for new Market Product and global clinical Investigational New Drug applications.

• Served as a liaison between several groups within the organization.
• Responsible for the CMC sections of Package Inserts, Summary of Product Characteristics, Patient Information Leaflets and Investigator's Brochures.
• Group responsibilities were to provide all CMC documentation for all clinical trial material submissions globally and new Market Product applications.
• Review, writing and compilation of documents for Drug Substances and Drug Products.
• Wyeth-Ayerst Team Accomplishment Award, 1999 (Twice, Rapamune Task Force and Minesse MRP Rapid Response Team).

Chemical Documentation Coordinator - CMC Administration - Berlex Laboratories, Inc. - Wayne and Montville, NJ

Prepared documents for the FDA (Drug Master Files, INDs, NDAs, and Environmental Assessments)

• Review, writing and compilation of documents for Drug Substances and Drug Products (mostly Berlex's diagnostic imaging agents).

Section Head/Scientist/Senior Organic Chemist - Medicinal Chem. Dept. - Berlex Laboratories, Inc. - Cedar Knolls, NJ

Directly responsible for supervising up to 3 Ph.D. level chemists and 2 bachelor level chemists.

• Chemistry co-chairman of Berlex's cardiovascular research program. This research program had approximately 60 scientists working full-time toward preparing and testing potent and selective enzyme inhibitors with cardiovascular activity.
• Designed and synthesized various novel antiarrhythmic agents along with following their biological testing.

Ph.D. - Organic Chemistry - Indiana University

B.A. - Chemistry (High Distinction) - Henry Rutgers Scholar - Rutgers University