Patrick Kim

Overseas Information Reporter at Ministry of Food and Drug Safety of Republic of Korea
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Contact Information
Location
Richmond Hill, Ontario, Canada, CA
Languages
  • English, Japanese, Korean Professional working proficiency

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5.0

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Byungkyu Kim

When I have worked for Youngjin Pharmaceutical, he was the head of the development team, and I has been the managing director of HR. He played very well as the leader of the development team, and also excelled in product planning and development capabilities. In particular, many people followed him because they considered communication important within the team and between departments. So I strongly recommend him as the best candidate for R&D part because I remember him as a person who is optimized for work and human management.

LinkedIn User

Dear the executive of company: Hello. This is Tae-heon Kim from South Korea. I work for Daewoong Pharmaceuticals company, which is located in South Korea and I am a member of the Patent team. From now on, I am going to tell you about Patrick Kim. I worked together with him at Yungjin Pharmaceuticals company, which is located in South Korea from April 2017 to March 2018. At that time, I woked on the Patent team, and he was the leader of the New Product Development Planning team. He is one of the most specialized pharmeceutical expert I have ever experienced in my life. When I first met him, I was deeply impressed with his excellent work and knowldge. He had lots of experiences about entire process of developing medicines, such as formulation research, clinical experience, product discovery and product development planning. He had excellent knowledge of pharmaceuticals as well. He always kept checking pipelines of global companies and global research trends. And, he proposed direction of product development to the executive of the company. Also, he talked freely with his colleagues and he explained the purpose and direction of their work. However, what I deeply impressed with him was his humanity. I have really impressed how positive and sincere attitude he is when it comes to people. He always try to help other people and treat everyone with repect. I also relied heavily on him. When he said he would leave South Korea, I shed tears in my heart. I highly recommend Patrick Kim to you. He will contribute to the development of your company and many people will probably make an example of him. Thank you.

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Credentials

  • Regulatory Affairs Certificate: Medical Devices
    Regulatory Affairs Professionals Society (RAPS)
    Mar, 2020
    - Oct, 2024
  • Regulatory Affairs Certificate: Pharmaceuticals
    Regulatory Affairs Professionals Society (RAPS)
    Nov, 2019
    - Oct, 2024

Experience

    • Government Administration
    • 1 - 100 Employee
    • Overseas Information Reporter
      • May 2020 - Present

      Ministry of Food and Drug Safety (MFDS) of the Republic of Korea, Seoul, South Korea • Provide daily updates on the latest regulations, guidelines, and policies for food, cosmetics, medical devices, and drugs in Canada including Health Canada and the Canadian Food Inspection Agency • Report information to the Ministry on recall actions due to safety issues, harmful substances, and side effects of food and drugs in Canada • Exceeded expectations by providing 115% of the anticipated information reports in 2021 Show less

    • Development & Regulatory Affairs Team Leader
      • Jul 2012 - Mar 2018

      Yungjin Pharmaceuticals (Specialized in ETC, API, and Global CMO), Seoul, South Korea • Completed the signing of joint development agreement - $3 million new product project • Planned, registered and launched Orphan Drug 1st generic (original: Pirespa), Hyperlipidemic 1st generic (original: Omacor), MRSA antibiotics 1st generic (original: Zyvox) • Achieved MFDS approval for new product (Rx 5, OTC 4 / 2017) - 100% product launch achieved • Doubled the portfolio of mid-to-long-term new products focused on five Therapeutic areas (CNS, CV, Metabolic, Respiratory, Pain) and established a new product development strategy • Managed planning and execution of regulatory affairs activities (e.g. preparation and submission of new registration, labeling, compliance, and post-approval variations) • Prepared and managed regulatory registration filings across product life cycles Yungjin Pharmaceuticals Key Accomplishments: • Reduced costs of clinical R&D projects under development, by signing joint development contracts: $3 million CAD clinical projects (Signed by 4 companies in 2015) • Signed a joint development contract for a hyperlipidemia treatment (Launched in 2016) • Increased the number of joint development projects by approximately 30%, for products such as erectile dysfunction, anticoagulant and diabetes treatment medicines • Planned, registered and launched the first generic versions of Pirespa (pirfenidone), and Zyvox (linezolid) in South Korea • Reduced the development period of new products by 20% by improving the development process and project management system • Conducted regular monthly development meetings with QA, Laboratory, Marketing and R&D departments, as well as the CEO and key executives, to brainstorm new product development ideas, and to update on the status of proposals and projects in progress • Was given the Employee Excellence Award from the CEO for contributing to the generation of profits through the development of new products Show less

    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • R&D Planning Team Assistant Manager
      • Jan 2011 - Jun 2012

      Kuhnil Pharmaceuticals (Specialized in R&D, Global CMO), Seoul, South Korea • Wrote a new Contract Manufacturing Organization (CMO) business plan for a production framework for freeze-drying and liquid injections, which was approved by the MFDS • Successfully completed injection product planning and increased product portfolio by 20% • Doubled domestic and international partners for joint development of new products Kuhnil Pharmaceuticals (Specialized in R&D, Global CMO), Seoul, South Korea • Wrote a new Contract Manufacturing Organization (CMO) business plan for a production framework for freeze-drying and liquid injections, which was approved by the MFDS • Successfully completed injection product planning and increased product portfolio by 20% • Doubled domestic and international partners for joint development of new products

    • South Korea
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • New drug development team - researcher
      • Jun 2004 - Dec 2010

      Kwangdong Pharmaceuticals (Specialized in Food, OTC, In-licensing), Seoul, South Korea • Planned and launched OTC products (including a Fermented drink, the company’s main product) • Demonstrated outstanding technical competence in laboratory and manufacturing setting with knowledge of GMP, GLP, GCP, and SOP • Developed and validated analytical testing procedures for drug substances and drug products • Was responsible for evaluating the efficacy of drug candidates and analyzing natural substances Show less

Education

  • 서울대학교 (Seoul National University)
    Master of Science - MS, Life Science(Immunology)
    1999 - 2004
  • 성균관대학교
    Ph.D. Candidate in Engineering, Management of Technology
    2014 - 2016
  • Kyung Hee University 경희대학교
    Bachelor of Science - BS, Biology
    1995 - 1999

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