Lilia Sneed
Regulatory Affairs CMC Professional
US - Remote
Summary
Regulatory Affairs CMC leader with 17+ years in the biopharmaceutical industry and deep, end-to-end expertise across Regulatory Affairs CMC, Quality, Compliance, Validation and Process Development, supporting cell therapy products throughout development, commercialization, and lifecycle management. Proven leader of CMC strategy, complex US submissions (IND amendments and post-approval filings), and change management with recognized subject-matter expertise in Change Control and QMS governance. Trusted Regulatory CMC representative to manufacturing sites and senior leadership, known for independent judgment, providing clear regulatory CMC strategy, inspection support, and strong cross-functional partnerships with Technical Operations, Quality Systems, Compliance, and MSAT. PhD-trained scientist with a track record of operating independently and delivering clear, strategic regulatory guidance to cross-functional teams and stakeholders.
Overview
18
18
years of professional experience
2
2
Certifications
Work History
Associate Director, Regulatory CMC
Kite Pharma
01.2024 - Current
- Represent Regulatory Affairs CMC as functional lead, Facilities, Equipment & Materials specialist, and serving as Regulatory CMC spokesperson across cross-functional and site-level forums.
- Lead the Global Regulatory CMC Spoke meeting, aligning regional and global stakeholders on regulatory business processes and manufacturing change readiness.
- Recognized expert in Change Control, with deep expertise in the QMS–GRASP connector for management of global and local change control records.
- Provide independent regulatory CMC assessments for global change controls and supplier notifications, evaluating regulatory impact across all jurisdictions when needed.
- Regulatory Affairs CMC representative for the TCF05 manufacturing site, delivering regulatory updates to the TCF05 Senior Leadership Team and playing an active role in shaping regulatory strategy.
- Established and sustained strong collaborative partnerships with Quality Systems, Compliance, and MSAT, enabling proactive issue resolution and Health Authority inspection readiness.
- Regulatory lead for multiple US post-approval submissions; currently leading Canada and Australia submissions.
- Support US and international regulatory inspections, including preparation, real-time support, and post-inspection follow-up activities.
Sr. Manager, Regulatory Affairs CMC
Kite Pharma
01.2022 - 12.2023
- Regulatory lead for submissions; Regulatory representative at CMCT and leader of process improvement initiatives, operating with minimal supervision.
- Prepared and submitted complex regulatory documents requiring broad cross-functional coordination for investigational and commercial products, aligned with ICH, regional requirements, scientific expectations, and internal policies/procedures.
- Provided strategic Regulatory CMC advice and communicate evolving regulatory requirements to project teams in a timely manner.
- Initiated and contributed to local and global process improvements impacting the Regulatory Affairs CMC function and partner organizations.
- Participated in Health Authority inspections to support approvability and marketability of cell therapy products.
QA Sr. Technical Manager, Quality, Engineering & Validation
Roche/Genentech
03.2018 - 01.2022
- Provided scientific/technical quality expertise on multidisciplinary teams reviewing validation packages supporting regulatory submissions.
- Critically reviewed validation studies for technical merit and compliance with internal procedures and regulations.
- Drove effective communication and rapid review cycles to meet aggressive timelines for products targeting marketing approval.
- Supported pre-approval inspection activities to strengthen product launch readiness and approvability.
Associate Regulatory Program Director (CMC) & Regulatory Training Specialist
Roche/Genentech
01.2017 - 01.2018
- Supported strategy and preparation for a complex multi-product regulatory submission, including assessments of network-wide changes.
- Reviewed and prepared multiple sections for US and global submissions; supported product technical teams assessing and managing manufacturing changes.
- Developed training materials supporting organizational change management and best practices for accelerated global initial marketing applications across the network.
QA Sr. Specialist, Compliance & Regulatory Audits
Roche/Genentech
01.2015 - 01.2017
- Prepared and executed GMP audit events with Health Authorities and partners; coordinated SME presentations, strategy meetings, and Health Authority response processes.
- Supported execution of Health Authority inspections including US FDA and multiple global health authorities; lead of EMA (EU) and COFEPRIS (Mexico) inspections.
Scientist & Group Leader, Process Development
Roche/Genentech
01.2008 - 01.2015
- Led process development and transfers to clinical sites as part of CMC; provided technical leadership and delegated project responsibilities.
- Authored and reviewed numerous CMC technical regulatory IND sections for US and global submissions; responded to Health Authority questions (US/CA/EU).
- Drove dossier harmonization and new language for key IND/IMPD sections for Purification; served as site point-of-contact.
- Managed and developed 10 staff members.
Education
Ph.D. - Biochemistry, Molecular & Cell Biology
Cornell University
Ithaca, NYM.Sc. - Biotechnology
ITESM
Monterrey, NL, MéxicoB.Sc. - Food Industries Engineering
ITESM
Monterrey, NL, MéxicoSkills
- Global CMC submissions & lifecycle management: US, Canada, and Australia CMC submissions, including IND amendments, BLA supplements, and CMC lifecycle management
- Regulatory CMC strategy & execution: experience as a functional representative; strong knowledge of regulatory expectations; contribution to CMCT decision-making and risk identification and mitigation
- Change management & governance: expert in change control business processes and supporting systems; regulatory impact assessor (US) and advocate for alignment with internal and regulatory expectations
- Quality, validation & compliance: solid understanding of process and equipment validation/qualification requirements; health authority inspection support and audit readiness
- Technical & scientific foundation: biopharmaceutical development, process development, and technology transfer
- Executive communication & influence: clear scientific writing and effective stakeholder engagement across multidisciplinary teams
Certification
Achieved Regulatory Affairs Certification (RAC-US)
AWARDS
Cornell University Outstanding Teaching Assistant Award (2002), Rómulo Garza Award for Research and Development (2002), Fulbright Scholarship (awarded) (2000), ITESM Honors & Excellency Award (1999); ITESM Honors Award (1997), Summer Research Fellowship — Mexican Academy of Sciences (1996, 1997)
Selected Publications
- Reviewer/approver of 100+ regulated documents and records (submissions, protocols, study reports, deviations, risk assessments, QMS records) across Kite Pharma and Roche/Genentech.
- Lilia R. Nunez, et al. Cell wall integrity MAPK pathway is essential for lipid homeostasis. J. Biol. Chem. (2008)Gaspar ML, Aregullin MA, Jesch SA, Lilia R. Nunez, et al. The Emergence of Yeast Lipidomics. BBA – Molecular and Cell Biology of Lipids (2007).
- Lilia R. Nunez and Henry SA. Regulation of 1D-myo-inositol-3-phosphate synthase in yeast. In Subcellular Biochemistry (2006).
Timeline
Associate Director, Regulatory CMC
Kite Pharma
01.2024 - Current
Sr. Manager, Regulatory Affairs CMC
Kite Pharma
01.2022 - 12.2023
QA Sr. Technical Manager, Quality, Engineering & Validation
Roche/Genentech
03.2018 - 01.2022
Associate Regulatory Program Director (CMC) & Regulatory Training Specialist
Roche/Genentech
01.2017 - 01.2018
QA Sr. Specialist, Compliance & Regulatory Audits
Roche/Genentech
01.2015 - 01.2017
Scientist & Group Leader, Process Development
Roche/Genentech
01.2008 - 01.2015
M.Sc. - Biotechnology
ITESM
B.Sc. - Food Industries Engineering
ITESM
Ph.D. - Biochemistry, Molecular & Cell Biology
Cornell University