BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Dir. Reg Affairs to work for a leading San Diego biotechnology company.
Please send resume to Shaun@biophaseinc.com
Responsible for all aspects of Regulatory strategy and submissions covering the development phases from preclinical, clinical, and registration to post approval requirements for assigned projects. Will be developing strategies, conducting meetings, and acting as a liaison with the FDA. Will work closely with other cross functional in Medical Affairs, Sales Operations, Marketing, etc.
- Provides regulatory strategies and plans
- Provides regulatory leadership to Team
- Ensures regulatory milestones are met to support regulatory approval strategies and overall business goals of the company
- Plans and leads meetings with regulatory Agencies on assigned projects
- Defines content, communicates and directs the organization in preparation of high quality and effective regulatory submissions
- Provides review of all documentation supporting regulatory submissions
- Maintains knowledge of pertinent regulations and guidance’s, interprets developments and provides recommendations to the project team and senior management team
- Recommends regulatory procedures and practices to assure adherence regulatory requirements
- Assists with oversight and management of vendors and consultants
- BS or MS degree in a life science or relevant discipline required; RAC certification preferred
- Min 10 years of pharmaceutical and/or biotech development, w/ 5-7+ years of in-depth regulatory experience
- 5 years’ experience in a management role with direct reports. Demonstrated ability to work through others.
- Direct experience with FDA requited, and international exp preferred. Post marketing FDA exp preferred.
- Experience with regulatory submissions and requirements including documents required for INDs, CTA’s, CTD’s and NDAs, supplements and Meeting Requests and associated briefing documents
- Working knowledge Nonclinical and multidisciplinary guidelines plus applicable regulations, federal and local
- Advanced knowledge and utilization of regulations and guidance’s
- Excellent team interaction skills and ability to work successfully in cross-functional teams
- Ability to work in a dynamic environment with a high degree of flexibility
- Independent management of complex projects
- Excellent written and verbal communication skills
- Knowledge of Canadian, EU and International regulatory requirements is preferred
- Moderate travel required, 10-15%