Albert Hong Email & Phone Number

Brisbane, California, United States

Fremont, California, United States

Leads and manages the timely submissions of multiple INDs, supporting cross-functional (CMC, non-clinical, and clinical) collaboration with multiple departmentsCoordinates, prepares, and reviews the compilation of technical documents and regulatory submissions (IND, NDA, CTA, ANDA, etc.). Received multiple successful original applications as regulatory program lead (oncology: TNBC, NSCLC)Formulates, implements, and oversees regulatory strategies for new regulations, standards… Show more Leads and manages the timely submissions of multiple INDs, supporting cross-functional (CMC, non-clinical, and clinical) collaboration with multiple departmentsCoordinates, prepares, and reviews the compilation of technical documents and regulatory submissions (IND, NDA, CTA, ANDA, etc.). Received multiple successful original applications as regulatory program lead (oncology: TNBC, NSCLC)Formulates, implements, and oversees regulatory strategies for new regulations, standards, policies and guidance issued by relevant regulatory bodies (FDA, ICH, regional requirements)Provides strategic and operational regulatory guidance/assistance (FDA, ICH) across various functions to receive early approvals for regulatory submissions Acts as the main regulatory representative in the role of the regulatory program leadOversees the organization of responses to inquiries from regulatory bodiesConducts weekly onsite meetings with department representatives to oversee project progress and maintain overall quality management and complianceAdministers and manages regulatory tools and electronic document management system (EDMS) Show less

Fremont, California, United States

Developed, documented, and implemented regulatory strategies for new regulations, standards, policies and guidance issued by relevant regulatory authoritiesAuthored, reviewed, and coordinated regulatory submissions to the FDA (establishment registration, self-identification, ANDA, IND, user fees, amendments, annual reports, etc.)Published, validated, and submitted drug applications in eCTD format in compliance with CFR and FDA/ICH guidanceEnsured company is in compliance… Show more Developed, documented, and implemented regulatory strategies for new regulations, standards, policies and guidance issued by relevant regulatory authoritiesAuthored, reviewed, and coordinated regulatory submissions to the FDA (establishment registration, self-identification, ANDA, IND, user fees, amendments, annual reports, etc.)Published, validated, and submitted drug applications in eCTD format in compliance with CFR and FDA/ICH guidanceEnsured company is in compliance with state and federal regulatory requirementsServed as US Agent for international clientsCollaborated with other company departments in support of regulatory submissionsDeveloped and edited new SOPs, IQ/OQ/PQ, product specifications. Reviewed and revised all Regulatory SOPs for applicability and relevance. Show less

Fremont, California, United States

Researched formulation and process development for small molecule oral solid dosage formsFocus on sustained-release solid dosage forms and sustained/targeted-release polymer technologies (single matrix tablets, film coated tablets, and compression coated tablets)Extensive experience at excipient candidate evaluationImproved bioavailability and solubility of poorly soluble and insoluble drug candidates Developed and optimized scale-up processing and formulation… Show more Researched formulation and process development for small molecule oral solid dosage formsFocus on sustained-release solid dosage forms and sustained/targeted-release polymer technologies (single matrix tablets, film coated tablets, and compression coated tablets)Extensive experience at excipient candidate evaluationImproved bioavailability and solubility of poorly soluble and insoluble drug candidates Developed and optimized scale-up processing and formulation from R&D/tech transfer through to clinical manufacturing Executed batch records and production according to cGMP manufacturing guidelines for Phase I & Phase II clinical trials. Successfully led multiple manufacturing batches of capsules, tablets, and gels.Experienced in literature and patent search, 505(b)(2) candidate evaluationIdentified and updated cGMP compliance issues to meet regulatory standardsDeveloped and edited new SOPs, IQ/OQ/PQ, product specifications. Reviewed and revised all Product Development SOPs for applicability and relevance.Supervised and executed training for interns and Research Assistants in R&DPerformed inventory management, in-process production sampling, training material development Show less

Bachelor Of Science - Bs, Biochemistry

Education record