Ella (Jiwon) Lee

Ella (Jiwon) Lee Email and Phone Number

Global Business Development @ Norbrook Laboratories ltd
London, GB
Ella (Jiwon) Lee's Location
London Area, United Kingdom, United Kingdom
Ella (Jiwon) Lee's Contact Details

Ella (Jiwon) Lee work email

Ella (Jiwon) Lee personal email

n/a
About Ella (Jiwon) Lee

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.

Ella (Jiwon) Lee's Current Company Details
Norbrook Laboratories ltd

Norbrook Laboratories Ltd

View
Global Business Development
London, GB
Website:
norbrook.com
Employees:
1032
Ella (Jiwon) Lee Work Experience Details
  • Norbrook Laboratories Ltd
    Global Business Development
    Norbrook Laboratories Ltd
    London, Gb
  • Medimab Biotherapeutics Ltd.
    Business Strategy Manager
    Medimab Biotherapeutics Ltd. Apr 2024 - Present
    Oxfordshire, England, United Kingdom
  • Outlier
    Ai Trainer
    Outlier Jun 2024 - Present
  • Candesic
    Business Analyst
    Candesic May 2023 - Aug 2023
    London, England, United Kingdom
  • Novotech
    Regulatory Start Up Associate Ii
    Novotech Dec 2021 - Aug 2022
    South 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
  • Novotech
    Regulatory Operations Associate
    Novotech Jun 2021 - Dec 2021
    Seoul, 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
  • Cenyx Biotech
    Regulatory Affairs Manager
    Cenyx Biotech Apr 2020 - Apr 2021
    South 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)
  • Alvogen
    New Product Launching Manager
    Alvogen Jul 2019 - Mar 2020
    South 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
  • Alvogen
    Quality Assurance Specialist
    Alvogen Apr 2018 - Jul 2019
    South 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)
  • Kist Europe
    Intern, Environmental Safety Department
    Kist Europe Sep 2016 - Feb 2017
    Saarbrücken, 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
  • Seoul National University
    Research Assistant
    Seoul National University Jan 2016 - Feb 2016
    Seoul, 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

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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