Nancy Motola, PhD, RAC — Regulatory, Compliance and QA Strategist

More than 30 years experience of regulatory, compliance and quality assurance program development in the pharmaceutical industry

Evolving from a research and chemical development scientist to a respected expert in regulatory, compliance and quality assurance programs, Dr. Motola’s vast experience includes building compliance organizations, gaining FDA approvals, and leading regulatory activities for INDs, NDAs and BLAs. Her background in small molecules and biologics, as well as chemical development and manufacturing, furthered her understanding of the challenges and regulatory requirements pharmaceutical companies face across a wide variety of therapeutic areas, while allowing her to expand her expertise to include quality assurance , as well as regulatory strategy development for small startups and large pharmaceutical firms.

Dr. Motola drove the approval process of several products, including Soliris, a monoclonal antibody for a rare hematological condition and other rare diseases (as SVP at Alexion Pharmaceuticals, Inc.) and Durlaza, a controlled release aspirin product for secondary prevention of acute cardiac events (as VP Regulatory Affairs, New Haven Pharmaceuticals Inc.). She previously served on the management teams for three small companies developing novel drugs and biologics and was responsible for gaining product approvals. Her background includes building and leading product compliance organizations, managing regulatory activities for several NDAs, BLAs and INDs, and oversight of post-marketing regulatory activities for four pharmaceutical companies.

Expertise 

• Compliance and quality assurance strategies
• Regulatory strategy development for INDs, NDAs and BLAs
• Regulatory Affairs guidance from discovery through product lifecycle.