Myleen Ignacio Leoncavallo
Clearwater Beach
Summary
Seasoned Regulatory Affairs expert with a proven track record of 10 approvals, adept in strategic regulatory planning and FDA negotiations. Demonstrates exceptional leadership in guiding clinical trial oversight and submission preparation, ensuring regulatory compliance. Skilled in risk assessment, with a focus on achieving pivotal regulatory milestones.
Overview
28
28
years of professional experience
1
1
Certification
Work History
Senior Regulatory Affairs Consultant
Biobridges
Ormond Beach
10.2023 - Current
President and Principal Regulatory Affairs Consultant
MyRA Biopharma Consulting, LLC
Clearwater
09.2023 - Current
Independent Senior Regulatory Affairs Consultant/Advisor
HighTide Therapeutics
Ormond Beach
03.2022 - 09.2023
- To two biopharmaceutical companies under Biobridges network providing part-time and full-time support for client organizations to include the following tasks:
- Work with the client’s clinical and regulatory teams to review the clinical strategy, identify gaps, and develop the regulatory strategy to obtain input and ultimately concurrence with FDA on a non-validated surrogate endpoint for a newer clinical program
- Work closely with the team members to develop the strategy for the Type C meeting, as well as jumping in to assist and/or lead as appropriate the request letter as well as the briefing documents to submit for the proposed Type C meeting
- Provide leadership, strategic and operational regulatory oversight, but not limited to general regulatory strategies and advice relative to drug development including pre- clinical and CMC regulatory requirements for their team and during their interactions with EC in Australia and the FDA
- Initiate interactions with cross-functional teams to ensure decisions and actions do not adversely impact the company’s objectives
- Serve as the primary point of contact for internal team for regulatory risk management, offering guidance to manage their resources and facilitate the transition from a non-
- GMP to a GMP operating environment and begin to generate an operational plan to support regulatory filings
- Originate or oversee the preparation and submission of documentation to support investigational packages throughout the world and ensure timelines are met (mid-year
- Direct negotiations with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues
- Maintain awareness of the global regulatory environment and assess the impact of changes on business and product development programs
- Facilitates policy and development of the standard interpretation of global regulation
- Build partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources
- Assist with the development, implementation, and enforcement of regulatory processes.
Vice President
01.2021 - 03.2022
Senior Vice President
Mirum Pharmaceutical Inc
Foster City
09.2019 - 03.2022
- Regulatory Affairs and Quality Assurance
- Provided strategic direction, global management and leading all regulatory activities for the Company including managing communications with the
- US and EU regulatory agencies for the main compound, HTD1801, in PSC
- NASH, and SHTG
- Worked with appropriate internal team members to direct and submit initial PIP applications and modifications, as needed
- Worked with technical and medical writing, and program management, to direct document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables
- Assisted in planning, writing, and reviewing Health Authority document submissions
- Provided guidance to the HighTide Team based on US and international regulatory policies, standards and expectations to ensure a fair balance of business and regulatory risk and comply with all applicable laws and regulations relating to business activities
- Drove Quality Assurance systems and processes to assure regulatory compliance for disposition and releasing of drug substances and drug products, managing regulatory inspections, handling drug complaints, leading investigations to resolve
- Quality issues and conducting document change control
- Designed and oversaw the execution of GXP and SOP training programs
- Managed/mentored Regulatory/Quality staff, as needed
- Managed the regulatory and Quality department budgets
- Oversaw Quality to assist in management of external inspections/assessments of facilities
- Served as the Regulatory and Quality representative on project teams and manage relationships with counterparts within Service Provider organizations.
Executive Director, Head
09.2019 - 01.2021
- Develop global regulatory strategies aimed at gaining the earliest possible regulatory approval in US, EU, and ROW for the main compound, LIVMARLI, for rare indications in ALGS, PFIC, and Biliary Atresia as well as for volixibat in other rare indications in PSC, PBC and ICP
- Develop effective working relationships with Regulatory Agencies and participate in Agency negotiations and serves as point of contact and represents the Company before regulatory authorities, including preparation of meeting agendas, materials, minutes and interpretation of regulatory correspondence
- Day-to-day management of Regulatory team members, including external consultants
- Leads the Regulatory function hiring, managing, and developing personnel as needed to support Mirum development programs & future commercial programs
- Leads the Regulatory function implementing systems to support Regulatory filings
- Leads the Regulatory function in the drafting and implementation of working practices and/or SOPs, as needed
- Participate in the development of innovative regulatory strategies for life cycle product management
- Serve as a key member of the product team and contribute to the development of product and business strategies to maximize the value of the company’s portfolio
- Participates in department initiatives to improve standards and systems internally and maintain relationships with other departments including consultants and vendors
- For the development product, prepares and directs the regulatory documentation to support clinical applications and marketing applications, as required, in accordance with regulations, guidance and legal obligations
- Interaction with the Regulatory, Clinical Research, Clinical Operations and other functions to ensure optimal execution of the agreed regulatory strategy for development medicinal products
- Represents the Regulatory Affairs function at cross functional submission, product team, and leadership meetings
- Responsible for maintaining strong knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams
- Work with technical and medical writing to direct and submit product prioritization designation requests, e.g
- Orphan drug, rare pediatric designation, breakthrough therapy, fast track, accelerated approval, PRIME, etc., in US and
- EU, respectively
- Works with appropriate internal team members to direct and submit initial PIP applications and modifications, as needed
- Work with technical and medical writing, and program management, to direct document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
Senior Director
03.2018 - 09.2019
Independent Executive Regulatory Affairs Consultant/Advisor
Ultragenyx Pharmaceutical Inc
Novato
01.2014 - 09.2019
- To the biopharmaceutical industry who provides part-time and full-time support for client organizations to include, but not limited to:
- Provide regulatory strategy to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures, and agency precedent
- Advise project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes
- Collaborate with regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables
- Maintain advanced knowledge of changing regulatory requirements and advise teams, as appropriate
- Interact with appropriate national/regional government regulatory agencies, as requested
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges
- Provide regulatory guidance on regulatory matters to different departments/functions of the client organization.
Director
03.2016 - 03.2018
Associate Director
01.2014 - 03.2016
Senior Regulatory Affairs CMC Consultant
Biomarin Pharmaceuticals, Inc
Novato
01.2012 - 01.2014
- Clinical CMC lead responsible for overseeing planning, preparation, and submission of the CMC sections of clinical trial applications globally for Phase 3 clinical trial and smaller trials for BioMarin’s main project
- O Ensure that the sections are complete, well-written, and meet all relevant requirements
- O Work with Technical Operations, Contract Manufacturing, Quality
- Supply to ensure timeliness of labels, import licenses, manufacturing authorizations, GMP certifications, and QP declarations o Develop excellent relationships with internal functional groups, contract manufacturing organizations, contract research organizations, and partners
- Assess proposed manufacturing changes and provide strategic regulatory guidance as to how to best implement changes globally
- Provide regulatory advice to technical operations departments based on knowledge of current requirements
- Manage interactions with FDA or other regulatory authorities for assigned project(s) as needed
- Review and manage CMC sections of the Company’s lead project VIMIZIM which was subject to the filing of a BLA and MAA and supported other programs, as needed, for the Regulatory Team as well as other development programs in BMN-190 (for Batten’s disease) and Peg-Pal (which was approved later to be PALYNZIQ)
President and Principal Regulatory Affairs Consultant
MyRA Biopharma Consulting, LLC
Windsor
08.2011 - 01.2014
- Pfizer, Pharmascent, and
- Valeant/Dow Pharmaceutical Sciences)
- Independent Regulatory Affairs Consultant to the biopharmaceutical industry who provides part-time and full-time support for client organizations to include, but not limited to:
- Interacted with US, Japan, and EU clients to find the Regulatory needs of each client in order to support the appropriate regulatory strategies to develop or market the client’s products
- Lead the drafting, review and compilation of submissions in support of clinical trials globally and for marketing authorizations in the US and EU for both small molecules and biologics
- Main contact and facilitated communications with FDA for clients who required a local agent in the US.
Senior Manager
Valeant Pharmaceuticals International
Petaluma
06.2010 - 08.2011
- Participate in meetings and interacting with members of the project team and sub- teams to convey regulatory requirements and guidances and develop a strategy to meet corporate goals for later compounds such as ACANYA (BIACNA in
- Canada), KINERASE, and JUBLIA as well as earlier compounds in the product pipeline
- Supervise junior staff within the department in the management of assigned R&D and commercial projects
- Signatory authority for the department as designated by the Head of Regulatory
- Affairs
- Assist in the development of regulatory strategies and compliance
- Review, approve, and prepare clinical, nonclinical, and “other” regulatory submissions: including INDs, ANDAs and NDAs, amendments, supplements
- PADERs, alert reports, annual reports, etcetera for dermatological products
- Review, approve, and prepare complete and accurate amendments, supplements, variations, CTAs, INDs, NDAs and other filings which present CMC information to ensure that CMC content is complete, well-written, and meets all relevant requirements to meet established timelines
- Act as the primary liaison with the FDA on assigned projects (CMC, Clinical and
- Nonclinical)
- Ensure post-approval regulatory compliance and other duties as assigned
- Provide regulatory counsel for drug development programs internally and externally (vendors, consultants, and clients) and maintain liaison with external clients, internal personnel and external consultants
- Ensure that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current regulatory requirements
- Manage activities and budgets to achieve program objectives
- Review and approve advertising and promotional materials as part of Promotional
- Review Committee (PRC)
- Oversee DDMAC submissions and responses (as part of the DDMAC surveillance program)
- Manage drug listing and registrations/licensing (including wholesale distributor) for dermatological products (US, Puerto Rico, Canada)
- Oversee and manage labeling revisions on assigned projects (Provide project support and coordination of labeling changes with departmental teams while applying applicable labeling regulations, provide redlines and coordination of timelines of new and revised labeling ensuring assigned deadlines are met, ensure accuracy and consistency of labeling, timeliness of changes and overall approval of label)
- Maintain current information of drug regulations, guidance documents, and standards applicable to pharmaceutical drug products and convey to appropriate departments when applicable
- Create and manage RA systems/procedures/SOPs within department and maintain corporate regulatory files
Senior Manager
03.2009 - 06.2010
Regulatory
Arena Pharmaceuticals, Inc
San Diego
01.2008 - 06.2010
- Project Lead/Core Team member responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures including programs for UX001 (GNEM), MEPSEVII, and CRYSVITA
- Regulatory Project Lead/Core Team member responsible to ensure regulatory commitments are met for assigned project
- Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and subteams
- Prepares and manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs
- Review and approve clinical, CMC, and nonclinical documents for accuracy and completeness and recommend modifications to enhance quality or presentation to support regulatory submissions
- Maintains knowledge of highly complex regulatory requirements up to current date, contributes to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management (as needed)
- Contributes to local and/or global process improvements which have a significant impact on business
- Interacts with FDA, EMA, Health Canada and other Health Authorities on project-related communications and activities, including facilitating agency meetings (i.e
- End of Phase-2, Pre-MAA, Scientific Advice, etcetera)
- Interacts with business partners, consultants and CROs on project-related communications and activities (i.e
- Development meetings, etcetera)
- Works in collaboration with other Regulatory colleagues to ensure the department provides a consistent regulatory voice and expertise to project teams across the company
- Responsible for recruitment, training, management, and professional development of regulatory staff.
Manager
01.2008 - 03.2009
- Participate in meetings and interact with members of the project team and sub- teams to convey regulatory requirements and guidances and develop a strategy to meet corporate goals
- Provide oversight of manufacturing, drug safety and clinical development in regards to ensuring compliance with applicable regulations and company policies
- Determine submission options and requirements; requests needed data, information, and documentation from various departments
- Manage the preparation and submission of regulatory documents including original INDs/CTAs, safety reports, annual reports, DMFs, NDAs/CTDs/eCTDs) within defined time schedule
- Review and approve clinical, CMC, and nonclinical documents for accuracy and completeness and recommend modifications to enhance quality or presentation to support regulatory submissions
- Prepare complete and accurate CMC submissions and ensure that CMC content is complete, well-written, and meets all relevant requirements to meet established timelines
- Review and approve amendments, CTAs, INDs, NDAs and other filings which present CMC information
- Correspond with FDA regarding investigational products and liaison with FDA reviewing divisions for assigned products, applications, and reports as needed
- Ensure that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current regulatory requirements
- Oversee and manage labeling activities (Maintain thorough knowledge of current rules and regulations governing labeling activities, partnering with project teams establishing and maintaining Target Product Profiles, coordinate and manage strategic labeling review committee across relevant functional areas, and provide recommendations regarding relevant Agency’s layout and format requirements, and regulatory precedent if guidelines are not available)
- Supported Advisory Committee preparations for BELVIQ
- Assist in the creation and maintenance of Regulatory Affairs standard operating procedures and processes
- Maintain current information of drug regulations, guidance documents, and standards applicable to pharmaceutical drug products and convey to appropriate departments when applicable
- Track and update regulatory project deliverables through communications with members of the regulatory department and other contributing departments
- Facilitate and head Regulatory-specific Due Diligence Activities
Manager
Neurocrine Biosciences, Inc
San Diego
05.2007 - 01.2008
- Manage & oversee regulatory affairs function for specific product line/functional group
- Lead coordination, writing, and assembly of regulatory submissions and appropriate amendments including INDs, NDAs, IMPDs, etc
- Review and approve clinical, nonclinical and CMC submissions’ relevant documentation for accuracy and completeness as well as to ensure compliance with applicable regulations and requirements
- Interact with Regulatory Authorities regarding assigned projects/programs
- Represent Regulatory Affairs on relevant project teams by providing advice and guidance to ensure clinical development plan and submissions met domestic regulatory requirements
- Maintain current knowledge of drug regulations, guidance documents, and standards applicable to biologic and pharmaceutical drug products
- Independently handle routine IND submissions (e.g., investigator packages, clinical protocols/amendments, general correspondence), including planning and follow-up with other departments, review/editing of documents, and publishing (hard copy and/or electronic)
- Track and update regulatory documentation, e.g., regulatory product indices, meeting minutes
- Monitor, interpret, applied and disseminated information related to FDA and other agency’s regulations and guidance documents, etc
- Supervise Administrative Assistant in the assembly, shipping, and archiving of regulatory submissions and Agency correspondence
- Review/audit documents from other departments for accuracy and compliance with FDA and ICH requirements (especially clinical documents such as protocols, reports, and consent forms, but also nonclinical and CMC documents on an as- needed basis)
Sr. Regulatory Affairs Associate, Senior Director of Regulatory
MediGene, Amylin Pharmaceuticals Inc
San Diego, La Jolla
05.2006 - 05.2007
- Work in consultation with Senior Manager and, Responsible for actively contributing to the development and implementation of regulatory strategy for assigned project and programs
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs for the U.S., including coordinating regulatory workflow, leading regulatory submission teams, tracking submission timelines, and reviewing technical documents (clinical, CMC, and non-clinical information) for IND (safety reports, information and protocol amendments, etc) and NDA (amendments, supplements, etc), and drug listing and establishment registration
- Contribute in the compilation of the IMPD and MAA to EU for Veregen
- Represent regulatory affairs on relevant project teams
- Interact with regulatory agencies (FDA, NIH, USAN) regarding assigned projects or programs, as appropriate
- Coordinate follow-up of orphan designations including ongoing compliance (G207)
- Review and approve advertising and promotional materials as part of Promotional
- Review Committee (PRC) with oversight from Manager
- Oversee DDMAC submissions and responses (as part of the DDMAC surveillance program)
- Ensure post-approval regulatory compliance and other duties as assigned
- Coordinate with outside vendor the transition of current label to SPL
- Oversee maintenance of onsite Quality Manual and QA SOP training files
- Perform regulatory intelligence functions as needed (researched on proposed, new, and revised regulations and guidance documents)
- Manage US regulatory electronic and paper files
Regulatory Affairs Associate II
03.2005 - 05.2006
09.2003 - 05.2006
Regulatory Affairs Associate
09.2003 - 03.2005
- Work in consultation with Regulatory Affairs Project Manager and Director on the strategy of specific project deliverables for the main compound, BYETTA and
- BYETTA LAR
- Clinical lead for clinical start-up activities for three compounds including review of regulatory packets required for initiation of clinical trials and GCP compliance
- Track and update key regulatory project deliverables through communications with members of the regulatory department and other contributing departments
- Support the preparation of information and overall compilation needed for investigational, marketing, and regulatory submissions and amendments, including INDs, IND amendments (protocol amendments, information amendments, safety updates, stability data, etcetera), annual reports, NDAs/CTDs, and NDA supplements (including orphan designated product METRELEPTIN)
- Coordinate application and follow-up of orphan designations including ongoing compliance (METRELEPTIN and GLP-1 [development stopped])
- Support Investigator INDs with company’s compounds
- Create guidelines for expedited safety reporting of clinical serious adverse events for regulatory department
- Create Training presentations/modules for Regulatory University at Amylin
- Responsible for coordinating, writing, editing and assembling regulatory submissions that include nonclinical, clinical and chemistry/manufacturing and controls documentation
- Review clinical, CMC, and nonclinical documents and reports and recommended to Manager of Regulatory Affairs modifications to enhance quality or presentation to support regulatory submissions
- Review and approve advertising and promotional materials as part of Promotional
- Review Committee (PRC) with oversight from Manager
- Oversee DDMAC submissions and responses (as part of the DDMAC surveillance program)
- Ensure post-approval regulatory compliance and other duties as assigned
- Develop and maintain good working relationships and open lines of communication with the staff of the regulatory affairs department and external consultants
- Regulatory intelligence responsibilities: Regulatory searches, information collection, and distribution of guidance, regulation documents, advisory committee meetings information found in transcripts and agendas, and summary basis of approvals of congestive heart failure drugs
- Manage and support FDA communication files in electronic database management system (Harbor) of assigned projects.
Regulatory Affairs Specialist
Idec Pharmaceuticals
La Jolla
08.2002 - 06.2003
- Entry-level Regulatory Affairs Support to Regulatory Affairs Team
- Work in consultation with Regulatory Affairs Manager on the strategy of specific project deliverables
- Supported and tracked key regulatory project deliverables through communications with members of the regulatory department and other contributing departments
- Representative on Study Management Team meetings
- Oversaw investigator submissions/updates to the IND
- Coordinated/facilitated the review of regulatory submissions by the Development
- Team
- Attended conferences and provided presentations to Regulatory Affairs Team.
Sr. Program Specialist
Covance, CRO
La Jolla
03.2000 - 08.2002
- Research of health insurance policies
- Operation of reimbursement hotlines -- full service reimbursement support by investigating benefits, responding to diagnosis and drug/device coding and billing questions and resolving denials for payment
- Operation of indigent care programs – screening of applicants for coverage options and help make costly new treatments available to patients with limited or no insurance
- Customer assistance on behalf of leading pharmaceutical manufacturers
- Monitored payer markets – tracked ongoing developments leading to customized reports on product-specific policy decisions and emerging reimbursement trends
- Updated computer systems on patient enrollment, denials, withdrawals, shipments, caller requests, and generate reports as necessary
- Gathered data and assisted in drafting program reports
- Reviewed reports and data for accuracy
- Wrote articles for client (Allergan) and dystonia foundations
- Actively participated in team processes to ensure work was completed in timely, efficient, high quality manner, and expected team performance measures are met; provide feedback to other team members
- Shared and communicated team needs and processes to other teams and to management
- Trained new program specialists on projects, assistance programs and team processes.
Analytical Chemist
Trilink Biotechnologies
San Diego
03.1999 - 03.2000
- Purification Techniques of oligonucleotides such as Polyacrylamide Gel
- Electrophoresis (PAGE) and column chromatography (anion-exchange, affinity and reverse-phase)
- Conjugation of oligonucleotides to specific dyes such as Texas Red, Tamra, Rox
- Dabcyl, Cy 3 and Cy 5, etcetera
- Synthesis Process Protocol – Deprotections, Work-ups and Ethanol Precipitation
- Proficiency in the use of laboratory equipment (analytical instruments) and sterile technique
- Collection and analysis of data and measurements obtained through spectroscopy and chromatography of synthetic oligonucleotides
- General laboratory maintenance, preparation of common lab reagents, pipetting, centrifugation, weighing of compounds and calculation of molar buffer solutions and pH.
Research Scientist PT
Scripps Research Institute
La Jolla
03.1999 - 07.1999
- Cell line maintenance and molecular biology techniques in support of lab and PI research goals
- Part of a multidisciplinary team performing techniques including biochemistry, cell and molecular biology and gene editing experiments
- Responsible for data analysis and maintenance of tissue, DNA, and other experimental samples
- Assists with general laboratory maintenance, including equipment maintenance and ordering of supplies.
Research Technician
Salk Institute
La Jolla
03.1998 - 07.1999
- Ordering and maintaining lab chemical stocks and equipment
- Design experiments and conduct basic biomedical research (Projects included fabricating microfluidic devices, isolating and cloning genes for in vitro translation, and developing confocal fluorescence microscopy-based expression assays)
- Perform research in collaboration with others for projects, analyze data and interpret results and investigate and modify procedures.
Research Technician
UCSD Biochemistry Dept.
La Jolla
07.1997 - 03.1998
- Biochemical Techniques such as protein purification, protein analysis and gel electrophoresis (SDS and Agarose)
- Preparation and analysis of ELISA and ELISA-like assays, RIA, centrifugation, radioisotope separation, etcetera
- Preparation and analysis of restriction digests, RNA and DNA isolation and chromatographic columns (affinity, anion/cation-exchange, paper and gel exclusion)
- Proficiency in the use of laboratory equipment and sterile technique
- Data collection and production of reports (charts, graphs and discussion of relevant information dealing with experiments) using Microsoft Office, Word and
- Excel.
Research Assistant/Laboratory Aide
UCSD Biology Dept.
La Jolla
01.1997 - 06.1997
- Assistance of projects involving degradability of anthropogenic marine sediments
- Sample extractions, sample and solution preparation and spectroscopic and chromatographic analyses
- General laboratory support – cleaning of glassware, bench work preparation, supply/stock maintenance and data entry.
Education
Master of Science - Medicinal and Pharmaceutical Chemistry
University of Southern California
Los Angeles, CA01.2005
Master of Science - Regulatory Science
University of Southern California
Los Angeles, CA01.2004
Clinical Trials Intensive Workshop Certification -
University of California, San Diego
La Jolla, CA01.2001
Bachelor of Science - Biochemistry and Cell Biology
University of California, San Diego
La Jolla, CA01.1999
Bachelor of Arts - English
University of California, San Diego
La Jolla, CA01.1999
Skills
- Regulatory strategy
- Submission preparation
- Risk assessment
- FDA interactions
- Regulatory compliance
- Clinical trial oversight
Affiliations
- Drug Information Association (DIA)
- Regulatory Affairs Professional Society (RAPS)
Certification
Regulatory Affairs Certified (US & EU)
Timeline
Senior Regulatory Affairs Consultant
Biobridges
10.2023 - Current
President and Principal Regulatory Affairs Consultant
MyRA Biopharma Consulting, LLC
09.2023 - Current
Independent Senior Regulatory Affairs Consultant/Advisor
HighTide Therapeutics
03.2022 - 09.2023
Vice President
01.2021 - 03.2022
Senior Vice President
Mirum Pharmaceutical Inc
09.2019 - 03.2022
Executive Director, Head
09.2019 - 01.2021
Senior Director
03.2018 - 09.2019
Director
03.2016 - 03.2018
Independent Executive Regulatory Affairs Consultant/Advisor
Ultragenyx Pharmaceutical Inc
01.2014 - 09.2019
Associate Director
01.2014 - 03.2016
Senior Regulatory Affairs CMC Consultant
Biomarin Pharmaceuticals, Inc
01.2012 - 01.2014
President and Principal Regulatory Affairs Consultant
MyRA Biopharma Consulting, LLC
08.2011 - 01.2014
Senior Manager
Valeant Pharmaceuticals International
06.2010 - 08.2011
Senior Manager
03.2009 - 06.2010
Regulatory
Arena Pharmaceuticals, Inc
01.2008 - 06.2010
Manager
01.2008 - 03.2009
Manager
Neurocrine Biosciences, Inc
05.2007 - 01.2008
Sr. Regulatory Affairs Associate, Senior Director of Regulatory
MediGene, Amylin Pharmaceuticals Inc
05.2006 - 05.2007
Regulatory Affairs Associate II
03.2005 - 05.2006
09.2003 - 05.2006
Regulatory Affairs Associate
09.2003 - 03.2005
Regulatory Affairs Specialist
Idec Pharmaceuticals
08.2002 - 06.2003
Sr. Program Specialist
Covance, CRO
03.2000 - 08.2002
Analytical Chemist
Trilink Biotechnologies
03.1999 - 03.2000
Research Scientist PT
Scripps Research Institute
03.1999 - 07.1999
Research Technician
Salk Institute
03.1998 - 07.1999
Research Technician
UCSD Biochemistry Dept.
07.1997 - 03.1998
Research Assistant/Laboratory Aide
UCSD Biology Dept.
01.1997 - 06.1997
Master of Science - Medicinal and Pharmaceutical Chemistry
University of Southern California
Master of Science - Regulatory Science
University of Southern California
Clinical Trials Intensive Workshop Certification -
University of California, San Diego
Bachelor of Science - Biochemistry and Cell Biology
University of California, San Diego
Bachelor of Arts - English
University of California, San Diego
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