Director, Regulatory Affairs
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.
- 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.