Nancy Bower Email and Phone Number

Accountable for strategic leadership and oversees the nonclinical regulatory activities for pipeline candidates for neurology and oncology projects, ensuring business timelines and compliance with all relevant regulations and guidelines. These activities include, but are not limited to drafting responses to nonclinical questions raised by Health Authorities, providing input on nonclinical regulatory strategy, providing nonclinical updates and reviews for annual reports, DSURs, PSURs, RMPs, GIPs, and CCDSs, and drafting nonclinical sections of briefing books for scientific advice. Participate in, or assign appropriate staff to participate in) face-to-face meetings with Health Authorities to support the effective progression of new drug candidates throughout development, and obtain mutual agreements with regulators on the course of development. Collaborate with internal teams including Global Drug Safety to ensure nonclinical safety assessment programs for pipeline candidates meet evolving global regulatory expectations. Collaborate with other Regulatory leaders in the business groups, subsidiaries, and support functions to optimize the global submission process and to address emergent nonclinical safety issues, and update information sharing related to nonclinical regulatory matters. Support corporate function strategic plans. Advise management on nonclinical regulatory issues and provide guidance on nonclinical matters. Accountable for maintenances of departmental operating procedures and policies to accomplish work more efficiently. Manage, train, and develop direct reports globally. Provide coaching and mentorship to other Global Nonclinical Regulatory Affairs members as appropriate.

Nonclinical Regulatory Affairs expert. Knowledge of nonclinical drug development, including toxicology, pharmacology and pharmacokinetics. Assist the company in the development of nonclinical regulatory strategies to support registration of new chemical entities. Knowledge of FDA, EU and ICH regulations and monitoring of the changing regulatory environment for the nonclinical sciences. Interactions with Health Authorities, including preparation of background materials, written responses to inquiries and face-to-face meetings. Manage the preparation of nonclinical modules of regulatory submissions including CTAs, and INDs, NDAs and MAAs in eCTD format. Serve on expert external industry working groups including EFPIA PDEG and the PhRMA LD-KITs for ICH S1, ICH S5, and ICH S11.

Nonclinical Regulatory Affairs expert. Knowledge of nonclinical drug development, including toxicology, pharmacology and pharmacokinetics. Assist the company in the development of nonclinical regulatory strategies to support registration of new chemical entities. Knowledge of FDA, EU and ICH regulations and monitoring of the changing regulatory environment for nonclinical. Interactions with Health Authorities, including preparation of background materials, written responses to inquiries and face-to-face meetings. Manage the preparation of nonclinical modules of regulatory submissions including CTAs, and INDs, NDAs and MAAs in eCTD format. Serve on expert external industry working groups.

Global Regulatory liason for TSU Fibrosis, supporting the development of botanical drug products, small molecules, biologics and novel drug-device combination products for fibrotic liver disease, wound-healing and scarring indications.

Preclinical expert in Regulatory Affairs. Knowledge of preclinical drug development, including toxicology, pharmacology and pharmacokinetics. Assist the company in the development of nonclinical regulatory strategies to support registration of new chemical entities. Knowledge of FDA, EU and ICH regulations. Scientific and regulatory review nonclinical dossiers to support clinical trials and marketing applications.

Nonclinical development of ethical pharmaceuticals including project team support and preparation and review of nonclinical registration summaries, including INDs, NDAs, eINDs, eCTDs and annual reports. Interaction with FDA as a nonclinical expert. Trained and supervised daily activities of 3 employees.

Supervised daily activities of 3 toxicology technicians. Responsible for rotating shifts as weekend facility supervisor. Prepared study protocols, draft study reports and other technical documents. Performed study activities on an as-needed basis. Participated in data collection system validation exercises.

Conducted nonclinical toxicology studies in support of new drug registration programs. Participated in validation of nonclinical data collection systems and methods development programs. AALAS certified Laboratory Animal Technician and Technologist.