Senior Manager, Regulatory Affairs
Resume:
Myleen Ignacio, M.S.
Windsor, CA 95492
******.*******@*****.***
Cell: 858-***-****
Work: 707-***-****
EXPERIENCE
Dow Pharmaceutical Sciences (Division of Valeant Pharmaceuticals International), Petaluma, CA 6/10 – PRESENT
Senior Manager, Regulatory Affairs
• 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
• Supervises 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
• Prepare regulatory submissions: including INDs, ANDAs and NDAs, amendments, supplements, PADERs, alert reports, etcetera for dermatological products.
• Reviews and approves for accuracy and completeness, all submission material for IND/NDA/ANDA submissions assembled and related amendments and supplements
• Ensure that all regulatory activities are in compliance with the latest regulatory guidelines
• Act as the primary liaison with the FDA on assigned projects
• Provide regulatory counsel for drug development programs internally and externally
• Maintain liaison with external clients, internal personnel and external consultants
• Manage activities and budgets to achieve program objectives
• Review and/or approve advertising and promotional materials
• Oversee DDMAC submissions and responses (as part of the DDMAC surveillance program)
• Manage drug listing and registrations/licensing (including wholesale distributor) for dermatological products
• 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 systems/procedures within department
Arena Pharmaceuticals, Inc., San Diego, CA 2/08 – PRESENT
Senior Manager, Regulatory Affairs (4/10 – 6/10)
Manager, Regulatory Affairs (2/08 – 3/10)
• 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
• 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.
• Correspond with FDA regarding investigational products and liaison with FDA reviewing divisions for assigned products, applications, and reports as needed.
• 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
Neurocrine Biosciences, Inc., San Diego, CA 9/07 – 1/08
Manager, Regulatory Affairs
• Managed & oversaw 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 submission relevant documentation for accuracy and completeness as well as to ensure compliance with applicable regulations and requirements.
• Interacted with Regulatory Authorities regarding assigned projects/programs.
• Represented Regulatory Affairs on relevant project teams by providing advice and guidance to ensure clinical development plan and submissions met domestic regulatory requirements.
• Maintained current knowledge of drug regulations, guidance documents, and standards applicable to biologic and pharmaceutical drug products.
Avera Pharmaceuticals, Inc., San Diego, CA 5/07 – 8/07
Manager, Regulatory Affairs
• Independently handled 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)
• Assisted with planning for and authoring/editing of more complex IND submissions, e.g., IND annual reports, briefing documents, CMC Information Amendments
• Tracked and updated regulatory documentation, e.g., regulatory product indices, meeting minutes
• Monitored, interpreted, applied and disseminated information related to FDA and other agency’s regulations and guidance documents, etc.
• Supervised Administrative Assistant in the assembly, shipping, and archiving of regulatory submissions and Agency correspondence
• Reviewed/audited 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)
• Acted as a liaison with FDA and assisted with development of regulatory strategies.
MediGene, San Diego, CA 6/06 – 5/07
Sr. Regulatory Affairs Associate
• Worked in consultation with Senior Manager and Senior Director of Regulatory Affairs
• 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
• Provided clear and valid regulatory guidance and direction to other departments and project teams
• Represented regulatory affairs on relevant project teams
• Interacted with regulatory agencies (FDA, NIH, USAN) regarding assigned projects or programs, as appropriate
• Coordinated with outside vendor the transition of current label to SPL
• Maintenance of onsite Quality Manual and QA SOP training files
• Performed regulatory intelligence functions as needed (researched on proposed, new, and revised regulations and guidance documents)
• Management of US regulatory electronic and paper files
Amylin Pharmaceuticals Inc., La Jolla, CA 9/03 – 5/06
Regulatory Affairs Associate II (3/05 – 5/06)
Regulatory Affairs Associate I (9/03 – 2/05)
• Worked in consultation with Regulatory Affairs Project Manager on the strategy of specific project deliverables.
• Clinical lead for clinical start-up activities for three compounds including review of regulatory packets required for initiation of clinical trials and GCP compliance.
• Tracked and updated key regulatory project deliverables through communications with members of the regulatory department and other contributing departments.
• Supported 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.
• Created guidelines for expedited safety reporting of clinical serious adverse events for regulatory department.
• Created 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.
• Reviewed clinical, CMC, and nonclinical documents and reports and recommended to Manager of Regulatory Affairs modifications to enhance quality or presentation to support regulatory submissions.
• Developed and maintained 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.
• Management and support of FDA communication files in electronic database management system (Harbor) of assigned projects.
Covance (CRO), La Jolla, CA 3/00 – 8/02
Sr. Program Specialist
• 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.
Trilink Biotechnologies, San Diego, CA 8/99 – 1/00
Oligonucleotide Chemist
• 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.
Scripps Research Institute, La Jolla, CA 3/99 – 7/99
Research Technician
• 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.
UCSD Biochemistry Dept., La Jolla, CA 7/97 – 3/98
Research Technician
• 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.
UCSD Biology Dept., La Jolla, CA 1/97 – 6/97
Research Assistant/Laboratory Aide
• 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.
PROFESSIONAL MEMBERSHIPS
• Drug Information Association (DIA)
• Regulatory Affairs Professional Society (RAPS)
EDUCATION
University of Southern California, Los Angeles, CA
Master of Science in Regulatory Science (Pharmaceutical Science) 2002 – 2004
• “Medical Writing Internship” at Amgen (2 months)
• “Regulatory Internship” at USC Alfred E. Mann Institute (2 months)
• “Clinical/Regulatory Internship” at Watson Pharmaceuticals (2 months)
University of California, San Diego, La Jolla, CA
Clinical Trials Intensive Workshop 2001
• Drug Development Process
• Good Clinical Practices (GCPs) – ICH and FDA
• Clinical Trial design and Protocol
• Case Report Form (CRF) Design
• Investigator Selection and Responsibilities
• Institutional Review Boards (IRBs) – informed consent
• Site and Study Management
• Monitoring
• Regulatory Responsibilities
• Statistical Data Analysis
Bachelor of Science in Biology/Biochemistry 1994 – 1998
• Dean’s List, 1995-1996
• Member of Alpha Gamma Sigma Honor Society
• Classes taken: Biochemistry with laboratory, Anatomy with Laboratory, General Biology with Laboratory, Organic Chemistry with Laboratory, General Chemistry with Laboratory, Molecular Biology, Biology, Cell Biology, Physiology, Microbiology Genetics, Endocrinology, and Neuroscience
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