The Regulatory Affairs (RA) Specialist will coordinate, compile, and submit regulatory submissions to the FDA in support of experimental cell therapy products developed at the Company. The focus of the cell therapy group is on first in human phase 1 clinical trials. The successful candidate will have experience with FDA submissions for such early-stage trials. Attention to detail and superior writing skills are required.
Essential Job Functions
- Prepares and maintains regulatory submissions for cell therapy projects, interacting with the FDA as needed.
- Coordinates, compiles and submits regulatory submissions, including IND annual reports, safety reporting, reporting to clinicaltrials.gov, and other required submissions.
- Represents RA on cross-functional project teams. Advises teams regarding content for FDA submissions and participates in reviews as needed.
- Designs and executes workflows and procedures regarding regulatory document tracking, indexing and retrieving, and disseminating information to project teams.
- Collaborates with and seeks guidance from appropriate internal and external resources.
- Complies with regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
- Knowledge, Skills, and Experience
- Bachelor’s Degree in Science preferred.
- Minimum of 1-2 years of regulatory experience in early phase clinical development.
- Must be familiar with US regulatory requirements for IND and early phase clinical studies.
- Experience with biologics, gene therapy, cell therapy, or other complex biologics desired.
- Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, clinical affairs, operations, or related area.
- Experience with word processing and spreadsheet software packages is required.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with the ability to effectively communicate and collaborate with a technical team
- Prioritizes and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail
The position is working from home, 20 weekly hours with at least half the hours in the evening, to overlap US west coast working hours.