Ryan C.W. Lo
Director, Head of Business Development & Regulatory Affairs at Amaran Biotechnology, Inc.- Claim this Profile
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Bio
Credentials
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Project Management Professional
Project Management InstituteJun, 2010- Sep, 2024 -
Regulatory Affairs Certification (RAC)
Regulatory Affairs Professionals Society (RAPS)
Experience
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Amaran Biotechnology, Inc.
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Taiwan
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Director, Head of Business Development & Regulatory Affairs
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Feb 2021 - Present
- Corporate Development and Fundraising for strategic/inorganic company growth - Business Strategy, Collaboration, and Partnership - Business Framework, covering Business Talks, RFP/RFQ, Cost Analysis, Quotation, Term Negotiation and Contracting. - PR. and Marketing - Regulatory Strategy and Consultancy for Pre-IND, IND, NDA, BLA, ANDA - Biopharmaceutical Substance and Injectable Product Fill & Finish CDMO Service - Corporate Development and Fundraising for strategic/inorganic company growth - Business Strategy, Collaboration, and Partnership - Business Framework, covering Business Talks, RFP/RFQ, Cost Analysis, Quotation, Term Negotiation and Contracting. - PR. and Marketing - Regulatory Strategy and Consultancy for Pre-IND, IND, NDA, BLA, ANDA - Biopharmaceutical Substance and Injectable Product Fill & Finish CDMO Service
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Orient Pharma Co., Ltd
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Taiwan
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Head of Regulatory Affairs
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Jun 2017 - Feb 2021
Acting as a leader for all self-developed IND/NDA/ANDA products from the OEP company group (Tablet, Capsule, Injectable and Patch) to global market (US, TW, ASEAN, EU, China, Africa etc.). Reporting to me includes the headquarter team of 5-7 people and the country regulatory affairs managers for project status. Leadership for team establishment and growth Lead for optimized regulatory path for all new product developments (NCE, 505b2, generics) at different stages, including meetings with authorities for non-clinical, clinical and CMC strategy and from Pre-IND to Marketing Application Lead all registration activities from planning, dossier preparation, coordination at headquarter level, then to execution and monitoring at regional level. Direct communication with authority officer as needed Coordinate with Business Development and Global Sales team for the partnership activities for global market Support Product Acquisition and Tech Transfer Participate in all group strategy and high level management meetings Attend worldwide key regulatory & science conferences Show less
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Regulatory Affairs Deputy Manager
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Sep 2016 - May 2017
Leading for all regulatory activities of Orient Pharma and OP Nano to US and Taiwan market. This would include cross-function communications/strategy meetings, internally with upper managements, production plant and BD, and externally with API supplier and CMO site for Pre-IND, IND, NDA, PIV ANDA and ANDA drug products, as well as those for establishment, drug listing, labeling, import, export, and the post-approval CMC change controls and pharmacovigilance.
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Supervisor, Regulatory Technical Services, Marketing
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Feb 2011 - Aug 2016
Being a supervisor under the department Director, I was leading a team of 5-7 people for overall 25-30 projects (small molecular or peptides), as one of the two subgroups in the regulatory technical services department. Recruit, train, supervise all the team members Setup milestones of deliverables with team members upon latest information and resources, internal from functional departments and/or external from customers and health authorities Monitor the progress of all scheduled tasks Review all official documents for customers or health authorities Lead complex CMC technical topics involving different department heads Problem solving and decision making; Lead for tough or systematic issues that involves upper managements and/or key accounts Direct interact with local health authority (TFDA) officer for a more efficient or simplified registration review system meeting global business operation Participate in monthly commercial project supplier review meeting Participated in Corporate Supply Chain Committee focusing on supplier chain management as well as streamline production and corporate investment Show less
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Specialist, Regulatory Technical Services of Marketing
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Jun 2007 - Feb 2011
Working in alliance with internal cross-functional team, I was engaged in the following activities: Responsible for all DMF (Drug Master File)-submission- and authority- query-relevant activities for the assigned projects and for worldwide markets including United States (IND, NDA, ANDA, 505(b)2 and PIV), Europe (DCP, MRP, CP and CE marking), Canada, Australia, New Zealand, Japan, Korea, China and Taiwan etc. Up to 4 or 5 projects at a time, including some major projects with more than 10 customers worldwide. Develop DMF/CEP submission strategies with our customers for the assigned projects, managing carefully for supporting drug products at their different stage of lifecycles covering also the post-approval variation Monitor and communicate on the new and changing regulations, internally and externally Lead internal resources to responds in a timely manner to the technical related questions from our distributors/agents/customers Interface with the customers to resolve the technical issues for the assigned products, through email communication, teleconferences, or face to face. Show less
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National Chung Hsing University
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Higher Education
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500 - 600 Employee
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Reserch Assistant at Institute of Biochemistry
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Mar 2003 - Aug 2004
As a research assistant, I was assigned to prepare the protein samples for NMR structure elucidation, using the DNA recombination technology in E. coli and Pichia. As a research assistant, I was assigned to prepare the protein samples for NMR structure elucidation, using the DNA recombination technology in E. coli and Pichia.
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Education
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2005 - 2007
National Tsing Hua University
Master's degree, Biotechnology -
2010 - 2012
Southern Taiwan University of Science and Technology
Bachelor's degree, Finance -
1995 - 1999
National Chung Hsing University
Bachelor's degree, Chemistry
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