Execute successful clinical and commercial oncology product approval and expansion activities by:-Constructing international submission strategies for over 40 geographies spanning Asia, US, Europe, and the Americas in coordination with a network of regional regulatory professionals -Leading trans-national, cross-functional manufacturing teams to implement global submission strategies -Creating effective responses to global health authority submission queriesEMD Serono, Billerica, US is an affiliate of Merck KGaA, Darmstadt, Germany

Merck Serono, Aubonne, Switzerland is an affiliate of Merck KGaA, Darmstadt, Germany

Guided successful commercialization of multiple oncology and rheumatoid arthritis biosimilar approvals in the US and EU by:-Developing and implementing manufacturing-related content strategies for international regulatory submissions-Improving cross-functional collaboration and communication channels to ensure consistent submission strategy and content-Evaluating and amending journal manuscripts and conference presentations for strategic alignment with organization objectives prior to publication-Mentoring over 70 colleagues on regulatory affairs best practices and career development

-Managed registration and renewal roadmaps for global expansion and supply continuity of human albumin products in over 20 Asia Pacific and Latin American geographies -Guided regulatory strategy during audits by Chinese health authorities to ensure successful licensure of manufacturing sites-Assessed global multi-facility process and analytical method updates for regulatory impact on Asia Pacific registered products

Baxter International divested Baxter Biosciences in 2015, creating Baxalta International.

Contract position. Analyzed updates to global biologics regulations and guidance documents to communicate potential impact on oncology product strategy, guaranteeing continued product compliance with global requirements.

Yonsei University Medical Device Development and Promotion Center-Advised executive management on program policy and business collaboration opportunities as the Regulatory Affairs functional lead-Collaborated with Korean medical device companies to ensure their commercial application content aligned with EU and US health authority standards-Mentored university undergraduates on medical product regulatory affairs skills and best practices-Collaborated with regulatory and industry leaders in Asia to align medical device clinical regulatory requirements as a Korea representative in the Asian Harmonization Working Party (AHWP)

Contract Position.

Contract Position.

Contract Position.