Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality
Core
Develop and execute regulatory submissions and strategy for medical device and biologics clients, managing interactions with regulatory bodies and leading therapy development ideas.
Role type
Director, Regulatory Affairs (Regenerative Medicine & Biologics)
Builds
Regulatory submissions (IND, BLA, 510(k), PMA) and strategic regulatory plans for client companies
Domain
Life Sciences / Regenerative Medicine / Biologics / Medical Devices
Deliverable
client delivery
Required skills
Regulatory submission development, FDA/ICH/ISO regulatory expertise, project management, team leadership and mentoring, budget management, business development, technical writing, cross-functional collaboration
Preferred skills
MS or PhD in scientific/regulatory discipline, experience with HCT/Ps, drugs, biologics, or combination products, statistical analysis knowledge
Technologies
MS Office, Excel, Word, PowerPoint
Responsibilities
Manage regulatory submissions and strategy, communicate with regulatory agencies and clients, lead new therapy ideas, manage and mentor staff, secure new clients, develop budgets and timelines, collaborate with clinical and quality departments
Seniority
Director, strategic leadership and team management