Director, Regulatory Affairs

Director, Regulatory Affairs

Overview

The organization is dedicated to developing therapies that address significant unmet needs in autoimmune diseases. The Director, Regulatory Affairs will serve as the regulatory lead for assigned programs, responsible for developing and implementing regulatory strategies in partnership with the Vice President of Regulatory Affairs. This individual will collaborate closely with cross-functional teams, subject matter experts, and regulatory operations to ensure successful execution of all regulatory activities.

Responsibilities

• In partnership with the Vice President of Regulatory Affairs, develop regulatory strategies for assigned programs across all stages of development, working closely with cross-functional team members.
• Serve as the primary regulatory point of contact for the program team and act as the liaison between the organization and the U.S. regulatory authority.
• Execute the regulatory strategy for the program, including activities such as pre-IND, EOP1, EOP2, IND, CTA, IMPD, NDA submissions, and applications for orphan designation, fast track, and breakthrough designation.
• Ensure that all regulatory commitments and requirements are fulfilled accurately and on schedule, including but not limited to annual reports, DSURs, and clinical trial registry submissions.
• Plan, prepare for, and support the leadership of regulatory agency meetings.
• Collaborate with external consultants to ensure the regulatory infrastructure remains current, well-maintained, and inspection ready.
• Maintain awareness of and stay current with changes in the regulatory landscape.

Qualifications

• 8+ years** of pharmaceutical industry experience, including **6+ years** in regulatory affairs, with experience in a small to mid-sized biotechnology environment.
• PhD, MD, PharmD, or another advanced scientific degree preferred.
• Demonstrated experience preparing for and leading regulatory agency meetings.
• Proven experience developing and completing pre-IND and IND submission activities; experience with NDA/BLA submissions and post-approval activities preferred.
• Experience working with novel small molecule therapies.
• Global regulatory clinical trial experience required, including experience with EU Clinical Trials Regulation (EU CTR).
• Experience with later-stage and pivotal registration studies required.
• Solution-oriented, highly collaborative team player.
• Excellent verbal and written communication skills.
• Highly motivated, decisive, and results-driven professional with the flexibility and creativity to thrive in a rapidly growing organization.
• Proven ability to manage multiple projects.