Associate Director / Director, Global Regulatory Affairs (Contract)

ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases. The company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA.

ImmPACT Bio is looking for an exceptional individual to join our growing team as Associate Director / Director of Regulatory Affairs. This position will report directly to the Head of Regulatory Affairs and be responsible for developing and executing the global regulatory strategy for one or more of our pipeline of early-stage CAR T products.

Primary Responsibilities:

• Interpret global regulations and guidance to identify risks and develop regulatory strategy for early-stage cell therapy products through product licensure

• Provide strategic regulatory guidance and assessments for cross-functional teams regarding change controls, comparability strategy, and vendor selection

• Represent regulatory affairs in product teams and health authority interactions

• Partner with cross-functional subject matter experts to draft, review, and compile global regulatory submissions including but not limited to INDs, CTAs, BLAs, health authority responses and briefing packages

• Review and QC documents to ensure that submissions and correspondence are of the highest quality in terms of content, organization, clarity, accuracy, and compliance

• Plan and manage timelines for complex regulatory submissions in accordance with corporate strategy/goals

• Manage and maintain current regulatory dossiers as required throughout the product development lifecycle

• Contribute to the development of departmental SOP and systems implementation

Basic Qualifications:

• BS/BA degree in a science or health related field with 12+ years of experience

• OR -

• MS/MA degree in a science or health related field with 8+ years of experience

• OR -

• PhD in a science or health related field with 5+ years of experience

• OR -

• Equivalent amount of education and experience

• In depth knowledge of global regulations/guidelines and understanding of evolving challenges and health authority expectations for cell therapies

• In depth knowledge of the drug development process and interdependencies relevant to regulatory authority submissions and interactions

• Experience leading IND, IMPD, BLA, or MAA filings

• Experience leading Type B or Type C health authority meeting preparations and discussions, and global equivalents

• Experience in crafting Breakthrough Designation, RMAT, Fast Track and/or Orphan Designation applications

Preferred Qualifications:

• Hands-on experience working in hematology/oncology and/or autoimmune disease therapeutic areas

• Cell therapy experience is a plus.

• Strong organization, time management, and attention to detail

• Excellent interpersonal skills including verbal and written communication

• Ability to build effective and collaborative relationships with cross-functional colleagues

• Ability to independently manage and prioritize multiple complex projects

• Experience with eCTD authoring templates and formatting tools preferred

At ImmPACT Bio we embrace transparency in our total rewards pay and benefits program and philosophy. We believe in offering and maintaining competitive compensation and benefits programs for our employees to attract and retain a talented, highly engaged workforce. Our compensation programs are focused on fair and equitable pay practices including market based and data supported base pay, an annual performance-based bonus plan, and equity grants (ISO) for new employees.

Compensation for the role will depend on several factors, including a candidate's qualifications, skills, competencies, and experience.

Salary Range

$107-$150 USD

ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.