Associate Director, CMC Regulatory Affairs
ImmPACT Bio USA
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, and with a subsidiary in Israel, developing novel cell therapies for treating cancer. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT Bio is looking for an exceptional individual to join our growing team as Associate Director of CMC Regulatory Affairs. This position will report directly to the Head of Regulatory Affairs and be responsible for supporting the development of CMC regulatory strategy for our pipeline of early-stage CAR T products.
- Interpret global regulations and guidance to identify risks and develop CMC 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 CMC regulatory affairs in product teams and health authority interactions
- Partner with cross-functional subject matter experts to draft, review and compile Quality modules for global regulatory submissions including but not limited to INDs, IMPDs, 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
- BA/BS degree in life sciences required, advanced degree preferred (PhD, MS, PharmD)
- 6+ years experience in CMC Regulatory Affairs, with prior experience in cell/gene therapy
- In depth knowledge of global CMC regulations/guidelines and understanding of evolving challenges and health authority expectations for cell therapies
- Experience leading Module 3 development for IND, IMPD, BLA, or MAA filings
- Experience leading Type B or Type C health authority meeting preparations and discussions
- 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
Compensation for the role will depend on several factors, including a candidate’s qualifications, skills, competencies, and experience.
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.