Dr. Frederick “Simon” Golec Jr., RAC

Dr. Golec is a scientifically degreed synthetic Organic Chemist and earned Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS). He is a Chemistry, Manufacturing and Controls (CMC) Regulatory sciences executive with demonstrated expertise in leading multidisciplinary, cross-functional teams to obtain Regulatory Approvals to market novel and innovative pharmaceutical drug substances and drug products and is experienced in the management and maintenance of Post-Approval, Life-Cycle Regulatory CMC Compliance and Conformance.

In 2010 Dr. Golec founded CMCRegAff, LLC with the primary focus to provide strategic, senior-level, executive CMC Regulatory Sciences Consulting Services to the pharmaceutical and biopharmaceutical industries on small molecule Drug Substance and Drug Product dosage form for all CMC Regulatory phases during the Investigational New Drug (IND, CTA) Development and planning, Submission and approval for New Drug Application (NDA, MAA) and the maintenance of Post-Approval, Life Cycle Regulatory CMC Quality Compliance and Conformance.

Dr. Golec’s pharmaceutical industry career included over 15 years (1995 – 2010) in management, leadership and strategic positions of increasing responsibility in CMC Regulatory Sciences with major, multi-national pharmaceutical companies (Pfizer, Wyeth, Bristol-Myers Squibb, DuPont Pharmaceuticals) and Sanofi legacy companies (Rhône-Poulenc, Rhône-Poulenc Rorer). Dr. Golec was the CMC leader for numerous Regulatory Approvals for New Molecular Entities (NME) and drug product dosage forms, reformulations and line extensions for medicines, including TAXOTERE^®, GLIADEL^® Wafer, LYBREL^®, CONBRIZA™, PREMARIN^® and PREMPRO^®—several of which achieved global sales of more than $US 1 billion.

Dr. Golec’s pharmaceutical industry career provided a deep grounding in Drug Substance / Active Pharmaceutical Ingredient (API) Manufacturing Sciences with over 18 years (1977 – 1995) in scientific, management and leadership positions in Chemical Process Research and Development of Active Pharmaceutical Ingredients (API) with Sanofi legacy companies (Rhône-Poulenc Rorer, Rorer Group, Revlon Health Care Group and Revlon). As such, Dr. Golec is uniquely qualified and possesses a direct, comprehensive understanding of the scientific and technical Development, Technology Transfer and commercial manufacturing activities that form the basis of a CMC Regulatory strategy and the Quality Modules 2 and 3 of the Common Technical Document (CTD) for innovator companies or with outsourcing activities with Contract Manufacturing Organizations (CMO).

Contact CMCRegAff, LLC to ask about our CMC Regulatory Sciences Consulting.