|Zosano Pharma, Inc. is a private specialty pharmaceutical company creating better products utilizing innovative drug delivery technology. Zosano Pharma is built upon the resourcefulness, talent, insight, and drive of our employees. We all share a common commitment to work toward achieving the Company? goals. This commitment provides the basis for a productive and collaborative effort, promotes personal and professional growth, and helps to ensure our continued success.
Director of Regulatory Affairs is a high-profile leadership position accountable for all company regulatory projects, including formulation and execution of US and EU regulatory strategy Provide guidance and support to R&D project teams to drive the drug development process.
Lead development of innovative regulatory strategy for all phases of drug development for investigational drug products
Provide strategic regulatory advice
Preparation of regulatory jurisdictions
Provide regulatory input into clinical development projects.
Provide oversight for the administration and maintenance of the document repositories and document control areas for Regulatory Affairs (both paper and electronic)
Represent Company at FDA and international governmental agencies to provide clinical and scientific information for product approvals
BS/MS, PharmD, or PhD in a scientific discipline
10 years relevant experience in Regulatory Affairs within the pharmaceutical industry
Demonstrated ability to effectively present information to top management and to regulatory agencies, with prior hands-on success in leading the design and development of formal meetings and presentations to FDA.
Excellent oral and written communication, as well as interpersonal, skills are required.
Must have in-depth knowledge of U.S. FDA regulations, guidance and regulatory process pertaining to drug development, approval, and advertising/promoting, inclusive of CMC, clinical and nonclinical requirements for applicants.
Direct experience with FDA, ideally including hands-on experience working with the FDA and International regulatory authorities from pre-approval to post-marketing, with a proven track-record of submissions and approvals with the FDA and/or other regulatory agencies.
State or Province