Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality

The Director, Regulatory Affairs will be a critical team member supporting regulatory strategy and submissions for the firm's clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas, as applicable.

Requirements

• Bachelor's degree in a scientific, engineering, or regulatory discipline (e.g., CMC); MS or PhD preferred.
• Minimum five years of experience in Regulatory Affairs related to FDA oversight of various human medical products (HCT/Ps, drugs and/or biologics, medical devices, and combination products)
• Project management and/or managerial experience
• Strong written and verbal communication and presentation skills
• Strong research, analytical, critical-thinking and problem-solving skills
• Strong professionalism with customer relations and managing client relationships
• Ability to lead a team effectively, mentor junior team members, and is accountable for team reaching target utilization, as required.
• Able to lead multiple projects with competing deadlines; takes initiative and ownership of results; demonstrates a high-level of self-accountability.

Benefits

• Incentive plans, bonuses, and/or other forms of compensation
• Range of health and welfare and/or other benefits