Director, Regulatory Affairs

Location
Fremont, California
Posted
Apr 12, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

Zosano Pharma is seeking an experienced regulatory professional to be our Director of Regulatory Affairs.

Description of Duties:

  • Provide ongoing regulatory support to Clinical, CMC, and Quality to address regulatory issues and questions.
  • Develop and provide oversight for development of key regulatory submissions including INDs, CTAs, NDAs.
  • Collaborate with development teams on applicable regulatory requirements and stage-gate reviews for development programs.
  • Author and manage the development of high-quality regulatory documents and submissions that may include, but not be limited to: INDs, CTAs, NDAs, submission amendments, meeting requests, briefing documents/meeting packages, requests for designation, and general regulatory correspondence with health authorities.
  • Review protocols, reports, and other development-related documents across all development areas (i.e., nonclinical, quality, safety, efficacy).
  • Review and provide regulatory and development input into clinical protocols, investigator brochures, study reports, and submission-level documents.
  • Function as primary company spokesperson with the FDA.
  • Develop and orchestrate infrastructure to manage advertising and promotional materials, as well as labeling for commercial products.

 

Position Requirements:

  • Degree in a Life Science or a related discipline with a higher degree preferable (e.g., PhD, PharmD, MSc, MPH) and a minimum of 10 years of regulatory affairs experience.
  • Small company experience is highly preferred.
  • Hands-on experience in late-state development through NDA approval combination products or transdermals is strongly preferred.
  • Success in building and leading regulatory teams.
  • An established track-record of successful regulatory submissions is required. Recent NDA submission experience is a plus.
  • Proven ability to manage complex projects, with the flexibility and adaptability to re-prioritize workload to meet changing timelines
  • Must be a hands-on team player accustomed to working in a fast-paced environment.
  • Must be articulate and able to communicate effectively both orally and in writing with employees at all levels of the global organization and external audiences.