Executive Director, Regulatory Affairs

• May 2023 - Present

Owner

• Sep 2021 - Present

https://www.linkedin.com/company/earthwise-pet-wayland/ Locally owned and operated pet supply and pet services. At EarthWise Pet, we believe inherently that pets are family. That’s why we’ve devoted more than four decades to ensuring our furry friends have access to high-quality nutrition, safe supplies and top-notch grooming, daycare, and self-wash. what sets us aside from our competitors? It is holistic pet dietian and nutritionist certification program. Certified Pet… Show more https://www.linkedin.com/company/earthwise-pet-wayland/ Locally owned and operated pet supply and pet services. At EarthWise Pet, we believe inherently that pets are family. That’s why we’ve devoted more than four decades to ensuring our furry friends have access to high-quality nutrition, safe supplies and top-notch grooming, daycare, and self-wash. what sets us aside from our competitors? It is holistic pet dietian and nutritionist certification program. Certified Pet Dietitians and Nutrition Specialists. The Certified Pet Dietitian certification is an advanced training program that educates learners on advanced canine and feline nutrition. Program participants must complete hundreds of hours worth of coursework, readings, and examinations. By visiting one of our stores, you have access to this extensive knowledge and experience to help your pet achieve optimal health and happiness. Nutrition consultations are always free to our valued customers and their fur babies. Show less https://www.linkedin.com/company/earthwise-pet-wayland/ Locally owned and operated pet supply and pet services. At EarthWise Pet, we believe inherently that pets are family. That’s why we’ve devoted more than four decades to ensuring our furry friends have access to high-quality nutrition, safe supplies and top-notch grooming, daycare, and self-wash. what sets us aside from our competitors? It is holistic pet dietian and nutritionist certification program. Certified Pet… Show more https://www.linkedin.com/company/earthwise-pet-wayland/ Locally owned and operated pet supply and pet services. At EarthWise Pet, we believe inherently that pets are family. That’s why we’ve devoted more than four decades to ensuring our furry friends have access to high-quality nutrition, safe supplies and top-notch grooming, daycare, and self-wash. what sets us aside from our competitors? It is holistic pet dietian and nutritionist certification program. Certified Pet Dietitians and Nutrition Specialists. The Certified Pet Dietitian certification is an advanced training program that educates learners on advanced canine and feline nutrition. Program participants must complete hundreds of hours worth of coursework, readings, and examinations. By visiting one of our stores, you have access to this extensive knowledge and experience to help your pet achieve optimal health and happiness. Nutrition consultations are always free to our valued customers and their fur babies. Show less

Sr Director, Regulatory Affairs CMC

• Apr 2022 - Dec 2022

Associate Director, Global Regulatory CMC Lead Gene Therapy

• May 2020 - Mar 2022

Director Global Regulatory Affairs Lead

• Sep 2019 - Dec 2019

Associate Director, Global Regulatory Affairs CMC

• Jun 2018 - Sep 2019

Responsible for developing and implementing regulatory affairs strategies related to Takeda’s Cx601 CMC global platforms—commercial and clinical applications. Additionally, I provide early regulatory strategy development for cell and gene therapy modalities from initial filing (including pre-pre-INDs) Phase I-III clinical trials, Phase IV and commercial related matters. Responsible for developing and implementing regulatory affairs strategies related to Takeda’s Cx601 CMC global platforms—commercial and clinical applications. Additionally, I provide early regulatory strategy development for cell and gene therapy modalities from initial filing (including pre-pre-INDs) Phase I-III clinical trials, Phase IV and commercial related matters.

Associate Director, Regulatory Affairs & Quality Systems

• Dec 2015 - Jun 2018

Stanford Laboratory for Cell and Gene Therapy In this role, I was responsible for developing and implementing regulatory affairs strategies and overseeing quality system activities related to Stanford’s School of Medicine investigator-initiated INDs from initial filing to Phase I/II/III clinical trials related to cell and gene therapy applications. Stanford Laboratory for Cell and Gene Therapy In this role, I was responsible for developing and implementing regulatory affairs strategies and overseeing quality system activities related to Stanford’s School of Medicine investigator-initiated INDs from initial filing to Phase I/II/III clinical trials related to cell and gene therapy applications.

Sr Lead Consultant (Regulatory Affairs)

• Jan 2014 - Dec 2015

•cGMP facility design and stem cell product manufacturing. •CMC development. •Regulatory compliance and strategy development for clinical trials: U.S (IND development) and Ex-U.S settings o Mexico (COFEPRIS), Ecuador (ONTOT), India (MoH, CDSCO), and U.S (FDA) •ISO 9001 compliance. •Quality Systems development: Quality Assurance and Quality Control. •Process Development: sample procurement, media development, stem cells from different sources. •Clinical protocol… Show more •cGMP facility design and stem cell product manufacturing. •CMC development. •Regulatory compliance and strategy development for clinical trials: U.S (IND development) and Ex-U.S settings o Mexico (COFEPRIS), Ecuador (ONTOT), India (MoH, CDSCO), and U.S (FDA) •ISO 9001 compliance. •Quality Systems development: Quality Assurance and Quality Control. •Process Development: sample procurement, media development, stem cells from different sources. •Clinical protocol development. •IRB protocol development and submission. •Informed Consent development. •CRF development. •International submissions for clinical studies. •Animal models for nonclinical testing: NHP and rodent models (rats and mice). •RFD filings for FDA. •R & D infrastructure and design. •Regulatory and Quality gap analysis: cGMP/GLP/GCP. •Authoring/Review of regulatory submissions (IND, BLA, NDA). •Preparation/Review of FDA briefing documents, meeting preparation and post-meeting review. •Ongoing application maintenance (amendments & supplements). Show less •cGMP facility design and stem cell product manufacturing. •CMC development. •Regulatory compliance and strategy development for clinical trials: U.S (IND development) and Ex-U.S settings o Mexico (COFEPRIS), Ecuador (ONTOT), India (MoH, CDSCO), and U.S (FDA) •ISO 9001 compliance. •Quality Systems development: Quality Assurance and Quality Control. •Process Development: sample procurement, media development, stem cells from different sources. •Clinical protocol… Show more •cGMP facility design and stem cell product manufacturing. •CMC development. •Regulatory compliance and strategy development for clinical trials: U.S (IND development) and Ex-U.S settings o Mexico (COFEPRIS), Ecuador (ONTOT), India (MoH, CDSCO), and U.S (FDA) •ISO 9001 compliance. •Quality Systems development: Quality Assurance and Quality Control. •Process Development: sample procurement, media development, stem cells from different sources. •Clinical protocol development. •IRB protocol development and submission. •Informed Consent development. •CRF development. •International submissions for clinical studies. •Animal models for nonclinical testing: NHP and rodent models (rats and mice). •RFD filings for FDA. •R & D infrastructure and design. •Regulatory and Quality gap analysis: cGMP/GLP/GCP. •Authoring/Review of regulatory submissions (IND, BLA, NDA). •Preparation/Review of FDA briefing documents, meeting preparation and post-meeting review. •Ongoing application maintenance (amendments & supplements). Show less

Sr. Manager, Regulatory Affairs

• Dec 2012 - Nov 2014

•Regulatory Authority/Collaborator Audit Support. •Global regulatory strategy development for products. •Drug Master File submission. •CMC development: IND and NDA a. Pre-approval support in the development phase b. Responsible for implementing plans to support CMC regulatory filings for responsible products c. CMC related activities for CTAs, INDs, NDAs d. Work closely with CMC teams in a matrixed… Show more •Regulatory Authority/Collaborator Audit Support. •Global regulatory strategy development for products. •Drug Master File submission. •CMC development: IND and NDA a. Pre-approval support in the development phase b. Responsible for implementing plans to support CMC regulatory filings for responsible products c. CMC related activities for CTAs, INDs, NDAs d. Work closely with CMC teams in a matrixed organization e. Represent regulatory affairs team for CMC pertinent related activities f. Responsible for providing regulatory advise/expertise on compliance with regulations and guidelines. g. CMC strategy alignment •Annual Reports/Amendments/Supplements submission. •NDA/BLA regulatory activities for global approved drugs. •IND regulatory strategy development. •Change Control Process; CAPA Process. •Lean Six Sigma experience for regulatory projects. Show less •Regulatory Authority/Collaborator Audit Support. •Global regulatory strategy development for products. •Drug Master File submission. •CMC development: IND and NDA a. Pre-approval support in the development phase b. Responsible for implementing plans to support CMC regulatory filings for responsible products c. CMC related activities for CTAs, INDs, NDAs d. Work closely with CMC teams in a matrixed… Show more •Regulatory Authority/Collaborator Audit Support. •Global regulatory strategy development for products. •Drug Master File submission. •CMC development: IND and NDA a. Pre-approval support in the development phase b. Responsible for implementing plans to support CMC regulatory filings for responsible products c. CMC related activities for CTAs, INDs, NDAs d. Work closely with CMC teams in a matrixed organization e. Represent regulatory affairs team for CMC pertinent related activities f. Responsible for providing regulatory advise/expertise on compliance with regulations and guidelines. g. CMC strategy alignment •Annual Reports/Amendments/Supplements submission. •NDA/BLA regulatory activities for global approved drugs. •IND regulatory strategy development. •Change Control Process; CAPA Process. •Lean Six Sigma experience for regulatory projects. Show less

Product Manager

• Jan 2011 - Dec 2012

•IND Development: CMC and IB. •Clinical protocol development. •CRF development. •Informed Consent Development. •IRB, DSMB, SMC interphase for clinical trials. •Product management: discovery phase to clinical trial phase. •Regulatory strategy and support for products in pipeline for clinical trials. •IND Development: CMC and IB. •Clinical protocol development. •CRF development. •Informed Consent Development. •IRB, DSMB, SMC interphase for clinical trials. •Product management: discovery phase to clinical trial phase. •Regulatory strategy and support for products in pipeline for clinical trials.

Regulatory Compliance and Quality Systems Manager

• Mar 2008 - Jan 2011

Responsible for pre-clinical and clinical regulatory strategies for several disease/trauma states; regulatory compliance programs, quality systems and safety programs; stem cell process development for clinical platform uses; regulatory strategies for human MSCs into clinical trial applications; IRB/SCRO activities for human biological procurement; regulatory strategies and quality system design; milestones to implement quality system (QA/QC) goals. Responsible for pre-clinical and clinical regulatory strategies for several disease/trauma states; regulatory compliance programs, quality systems and safety programs; stem cell process development for clinical platform uses; regulatory strategies for human MSCs into clinical trial applications; IRB/SCRO activities for human biological procurement; regulatory strategies and quality system design; milestones to implement quality system (QA/QC) goals.

Head of Regulatory Compliance/Quality Systems

• Feb 2003 - Oct 2007

Regulatory Compliance and Quality System for use in GMP/GLP settings; regulatory strategies for human stem cells products into P1 clinical trials EX-US, e.g. South America; IRB/SCRO/ESCRO experience; Human tissue outsourcing for stem cell isolation. Regulatory Compliance and Quality System for use in GMP/GLP settings; regulatory strategies for human stem cells products into P1 clinical trials EX-US, e.g. South America; IRB/SCRO/ESCRO experience; Human tissue outsourcing for stem cell isolation.

Process Development Scientist

• Jan 2002 - Dec 2004

NSO and CHO expereince. Process development techniques to obtain optimal growth and antibody production for cell lines. Worked with manufacturing team under cGMP regulations for scale up experiments. cGMP experience. Multiple small and large scale bioreactors for antibody purification for use in clinical trials. Development of clinical products from the R&D phase to the clinical grade phase for Phase I to III clinical trials. NSO and CHO expereince. Process development techniques to obtain optimal growth and antibody production for cell lines. Worked with manufacturing team under cGMP regulations for scale up experiments. cGMP experience. Multiple small and large scale bioreactors for antibody purification for use in clinical trials. Development of clinical products from the R&D phase to the clinical grade phase for Phase I to III clinical trials.

Laboratory Technician

• Jan 2002 - Dec 2002

Cystic Fibrosis assays under a CLIA certified facility. Hands-on experience in running TTGE gels, robotic pipettor, multiple thermal cycler and PCR techniques; was formally trained in QA/QC protocols; involved in research for validation protocols. Sequencing patient samples to detect mutations via analysis of sequenced results and TTGE gels; Training new personnel on all laboratory protocols; Analyzing genetic profiling for all patients tested to detect possible mutations and submit all new… Show more Cystic Fibrosis assays under a CLIA certified facility. Hands-on experience in running TTGE gels, robotic pipettor, multiple thermal cycler and PCR techniques; was formally trained in QA/QC protocols; involved in research for validation protocols. Sequencing patient samples to detect mutations via analysis of sequenced results and TTGE gels; Training new personnel on all laboratory protocols; Analyzing genetic profiling for all patients tested to detect possible mutations and submit all new mutations into a databank for novel Cystic Fibrosis mutations. Show less Cystic Fibrosis assays under a CLIA certified facility. Hands-on experience in running TTGE gels, robotic pipettor, multiple thermal cycler and PCR techniques; was formally trained in QA/QC protocols; involved in research for validation protocols. Sequencing patient samples to detect mutations via analysis of sequenced results and TTGE gels; Training new personnel on all laboratory protocols; Analyzing genetic profiling for all patients tested to detect possible mutations and submit all new… Show more Cystic Fibrosis assays under a CLIA certified facility. Hands-on experience in running TTGE gels, robotic pipettor, multiple thermal cycler and PCR techniques; was formally trained in QA/QC protocols; involved in research for validation protocols. Sequencing patient samples to detect mutations via analysis of sequenced results and TTGE gels; Training new personnel on all laboratory protocols; Analyzing genetic profiling for all patients tested to detect possible mutations and submit all new mutations into a databank for novel Cystic Fibrosis mutations. Show less

Research Associate MBRS

• Sep 1997 - Dec 2001

Molecular Sub-Cloninc of Moloney Murine Leukemia Virus in non-expressor cells and Cloning of Hammerhead Ribozymes. Worked with different molecular biology techniques, such as gel electrophoresis, viral isolation, real time PCR, RT-PCR, PCR, primary cell culture, transfection methods and transformation methods. Molecular Sub-Cloninc of Moloney Murine Leukemia Virus in non-expressor cells and Cloning of Hammerhead Ribozymes. Worked with different molecular biology techniques, such as gel electrophoresis, viral isolation, real time PCR, RT-PCR, PCR, primary cell culture, transfection methods and transformation methods.