Ella (Jiwon) Lee Email and Phone Number
Ella (Jiwon) Lee work email
- Valid
Ella (Jiwon) Lee personal email
I’m a seasoned professional with extensive experience across the pharmaceutical industry, having worked in big pharma, small biotech companies, CROs, and pharmaceutical consulting. My career has spanned several key roles, starting as a Quality Assurance (QA) Specialist and evolving into Regulatory Affairs (RA) Manager, Business Analyst, and now Business Planning & Operations Manager.In my early roles, I focused on ensuring regulatory compliance and maintaining product quality for global markets. As I transitioned into business analysis and planning, I began using my technical expertise to support strategic decisions, streamline operations, and drive business growth in both emerging biotech startups and well-established pharmaceutical companies.Having worked across different sectors, I bring a unique blend of technical, regulatory, and business insights, allowing me to effectively bridge the gap between regulatory requirements and business strategies. My passion lies in driving innovation and operational efficiency in healthcare, and I thrive in fast-paced, dynamic environments that require cross-functional collaboration.I’m dedicated to contributing to projects that improve patient outcomes, optimize business operations, and ensure alignment with the rapidly changing regulatory landscape.
Norbrook Laboratories Ltd
View- Website:
- norbrook.com
- Employees:
- 1032
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Global Business DevelopmentNorbrook Laboratories LtdLondon, Gb -
Business Strategy ManagerMedimab Biotherapeutics Ltd. Apr 2024 - PresentOxfordshire, England, United Kingdom
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Ai TrainerOutlier Jun 2024 - Present -
Business AnalystCandesic May 2023 - Aug 2023London, England, United Kingdom -
Regulatory Start Up Associate IiNovotech Dec 2021 - Aug 2022South Korea• Successfully finalized Covid-19 treatment clinical trials under Emergency Use Authorization in 10 sites within 6 months• Supervised change of clinical trials plan and managed clinical trials to apply to the Ministry of Food and Drug Safety to approve change of investigational new drugs (IND) (about 8 phase I – III clinical trials per month)• Provided compliance tracker to sponsors for assigned projects and assisted in preparation of audits and regulatory inspections -
Regulatory Operations AssociateNovotech Jun 2021 - Dec 2021Seoul, South Korea• Perform quality checks on submission assessment and safety notification letters of expedited and periodic reports to Regulatory Authorities (RA), Ethics Committees (EC) and Institutional Review Boards (IRB) for global clinical trials• Managed submission studies including a review of the Safety Management Plan (SMP) and safety database set up -
Regulatory Affairs ManagerCenyx Biotech Apr 2020 - Apr 2021South Korea• Generated insights to understand how inorganic nanoparticles in clinical trials are perceived; where results were used in investor pitches which got $18M worth of Series A investment funding.• Secured a partnership with a leading global CDMO on a 20% less budget to manufacture subarachnoid hemorrhage treatment• Controlled new drug (CX213) development project (Responsible for the issue, designed a clinical trial protocol and analysed regulatory requirements, and communicated with R&D departments)
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New Product Launching ManagerAlvogen Jul 2019 - Mar 2020South Korea• Launched generic drugs (Qsymia cap.) by preparing product quality reports including product improvements by 5%, feasibility for revalidation, change in CTD or SOP regarding GMP guidelines, change control, stability studies, complaints, recall, etc -
Quality Assurance SpecialistAlvogen Apr 2018 - Jul 2019South Korea• Organized new drug product audit: Responsible for preparing yearly audit plan, arranging audits, finalizing audit reports, acquiring CAPA, and closing out audits (about 100 products per year)• Conducted supplier risk assessment for excipients, primary/secondary packaging, and service vendors (about 400 cases per year) -
Intern, Environmental Safety DepartmentKist Europe Sep 2016 - Feb 2017Saarbrücken, Saarland, Germany• Developed Biocidal Products Regulation guidebook for small-sized companies who aimed to export biocidal products to the EU• Advised 3 companies about EU REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) guideline• Analysed mixture toxicity tests by operating HPLC, GC, and NMR equipment and got 50 kinds of results for the research paper
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Research AssistantSeoul National University Jan 2016 - Feb 2016Seoul, Seoul, South Korea• Research about 5-Acetoxymethyl furfural (AMF) and 2,5-dimethylfuran (DMF) synthesis• Total synthesis experiment• Using HPLC, GC equipment
Ella (Jiwon) Lee Education Details
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Chemical Engineering -
Environmental Chemistry
Frequently Asked Questions about Ella (Jiwon) Lee
What company does Ella (Jiwon) Lee work for?
Ella (Jiwon) Lee works for Norbrook Laboratories Ltd
What is Ella (Jiwon) Lee's role at the current company?
Ella (Jiwon) Lee's current role is Global Business Development.
What is Ella (Jiwon) Lee's email address?
Ella (Jiwon) Lee's email address is el****@****sic.com
What schools did Ella (Jiwon) Lee attend?
Ella (Jiwon) Lee attended Ucl, Kyung Hee University, Universität Trier.
Who are Ella (Jiwon) Lee's colleagues?
Ella (Jiwon) Lee's colleagues are Shauna Carr, Vedang Ganpatye, Sarah Hamilton, Nicole Clitheroe, Caolan Mckerr, Deirbhle Cunningham, Patrick Mcmahon.
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