This late-stage biotechnology company is developing first-in-class T Cell based cancer immunotherapies. They are seeking a Regulatory Affairs Director (or Assoc Director) who can develop and execute on regulatory strategies for their programs in development and lead regulatory filings. You will work closely with cross-functional teams and interact directly with US health authorities. This is a remote role! With two programs in Phase 3, this company offers innovative science, competitive compensation, and a patient-focused company culture. Now is an exciting time to join this innovative organization and improve the lives of patients in need!
- Provide regulatory strategy and execution for a portfolio of immune-oncology programs in development.
- Work closely with functional leaders to 1) create the optimal development path for product candidates, 2) negotiate optimal development paths within internal cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.
- Plan, manage and create regulatory submissions including INDs, BLAs, CTAs, etc.
- Ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
- Leads cross-functional teams in preparing for health authority meetings, including pre-IND, pre-BLA and Type C meetings.
- Provide regulatory advice to cross-functional teams to achieve timely and efficient regulatory submissions while ensuring compliance with applicable regulatory requirements.
- Effectively plan and prioritize regulatory activities in close collaboration with leads from other functional areas.
- Ensure that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
- Work within the department and with other functional areas on process improvements.
- Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- Eight or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Direct experience in preparing major drug applications (NDA, BLA, NDS, MAA, etc) required.
- Prior oncology and/or Immune-oncology experience required. Late stage oncology experience highly desired.
- Regulatory experience with pre-clinical and clinical drug development, along with lifecycle maintenance and compliance.
- Experienced in creating and negotiating the clinical-regulatory aspects of oncology programs.
- Solid working knowledge of FDA requirements. Ex-US experience a plus.
- Experience interfacing directly with FDA including meeting preparation.
- Strong organizational and planning skills.
- Proven ability to communicate effectively and efficiently cross functionally and with regulatory agencies.
- Ability to build positive relationships with co-workers of various backgrounds and expertise.
- Outstanding written and verbal communication skills.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
- Must be comfortable with ambiguity within an evolving company.