VP/Senior Director, Regulatory Affairs - Los Angeles, United States - Atlas Search

Description

We are currently partnered with a fast growing pharmaceutical company that is seeking a

VP/Senior Director, Regulatory Affairs & Quality Assurance.

This is a great opportunity to become part of a company at the forefront of advancing CAR T cellular therapy through innovative platforms engineered to offer superior safety, effectiveness, and accessibility when compared to traditional autologous CAR T therapies.

We're looking for an individual with CAR T Cellular Therapy experience to serve as the Quality and Regulatory Affairs lead to support U.S.

regulatory activities related to our cellular therapy programs, including the planning, development and execution of regulatory submissions and the overseeing of CMC Regulatory and Quality Assurance activities.

Build a regulatory team and maintain strong leadership while supporting the professional development of new hires
Develop and implement cross-site department policies, processes and SOPs
Interact with the FDA and other regulatory agencies to seek scientific and regulatory advice for planned phase 1 studies
Work on all aspects of planning, creating, publishing, submitting, and archiving of regulatory submissions to health authorities
Oversee compliance and quality activities
Lead the implementation, validation, and operation of eCTD and electronic document management systems (e.g. Veeva) and other publishing and submissions technology projects


Requirements:
Bachelor's degree with a minimum of 10+ years of related work experience in the biotech/pharma industry with 5+ years of managerial experience developing and leading a team
CAR-T Cell Therapy, Gene Therapy and / or Oncology experience required
Relevant knowledge of CMC, QA, clinical and nonclinical science
Expert knowledge of regulatory submission publishing standards and procedures, including electronic document management systems and regulatory publishing software
Robust understanding of evolving Health Authority (HA) standards and procedures for regulatory submissions
Demonstrated proficiencies in leading successful health meetings and interactions

#J-18808-Ljbffr