Sarah Mohs

Sarah has thorough, up-to-date knowledge and firm understanding of global regional regulations and guidances, directives, as well as ICH guidelines, ISO standards, and pharmacopeia.

Sarah Mohs is an expert in CMC Regulatory and joined Syner-G in 2016. She has over 25 years of regulatory experience in drug development for small molecule and biotechnology drug products, drug-device combination products, and medical devices. Sarah’s experience is in program management, team building, and intra-departmental leadership. She has successfully contributed to and managed numerous global clinical trials and marketing applications, as well as amendments and post approval supplements.

Sarah has thorough, up-to-date knowledge and firm understanding of global regional regulations and guidances, directives, as well as ICH guidelines, ISO standards, and pharmacopeia. She is experienced with US, Canadian, European, and Japanese regulatory submissions. Additionally, she is a proficient technical writer with strong interpersonal, oral, and written communication skills. She facilitates collaboration of cross-functional departments to develop, manufacture, and validate investigational products under highly aggressive development timelines

Sarah’s specialties are late-stage CMC development and marketing applications, accelerated CMC development in expedited programs, client-focused health agency interactions to achieve regulatory flexibility, and creative development pathways. Sarah’s previous experience includes TARIS Biomedical, Stryker Biotech, Sepracor, and PPD Development. Her Chemistry degree is from the University of Wisconsin, Madison.

• A Proficient Technical Writer with strong interpersonal, as well as oral and written, communication skills
• Experienced with US, Canadian, European & Japanese regulatory submissions
• Facilitates Collaboration of cross functional departmentsto develop, manufacture, and validate investigational products