Director, Regulatory Affairs
- Employer
- Zosano Pharma Corporation
- Location
- Fremont, California
- Start date
- Apr 12, 2021
View more
- Discipline
- Quality, Regulatory, Regulatory Affairs, Research/Documentation, Science/R&D, Biotechnology, CMC
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
You need to sign in or create an account to save a job.
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.
You need to sign in or create an account to save a job.
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert