Colleen Johns

Regulatory professional with 30+ years of pharmaceutical experience in areas of regulatory CMC, quality management, formulation development, and quality oversight of process validation. Accomplished at developing and executing regulatory strategies that resulted in successful drug applications for human and veterinary products.

Prepared and managed product applications across all phases of development covering several therapeutic areas including: Analgesia, Anti-infective, Cardiovascular, Gastroenterology, Pulmonary, Generic Drugs, CVM.

Possess strong project planning skills. Highly organized and skilled in effective communication. Ability to prioritize work to meet timelines and own accountability/responsibility for deliverables. Foster conducive working relationships to develop high performing teams.