
Lin Wu
Honest and experienced regulatory affairs professional with over nearly fifteen years of experience in commercial regulatory affairs and... | Greater Boston, Greater Boston, United States
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Lin Wu’s Emails lw****@su****.com
Lin Wu’s Phone Numbers 1301838****
Social Media
Lin Wu’s Location Greater Boston, Greater Boston, United States
Lin Wu’s Expertise Honest and experienced regulatory affairs professional with over nearly fifteen years of experience in commercial regulatory affairs and operations. Subject matter expert and trusted advisor, well-versed in leveraging background in drug development and regulatory science to conduct regulatory reviews and to ensure advertising and promotional materials comply with the labeling requirements and FDA regulations. Consistently serves as an internal expert on FDA and international regulations, guidance, and enforcement trends governing the promotion of prescription drugs, medical devices, and combination products. Rewarded by leaders of the company for thoroughly reviewing and assessing proposed promotional items to evaluate their completeness, accuracy, and compliance with the regulatory requirements and regulations. Experienced in policy or standard operating procedures development and staff management positively impacting overall productivity. Demonstrated ability of providing regulatory strategic oversight for multiple products and therapeutic areas to help to make sure regulatory compliance of the promotional materials generated for US or global marketing, including but not limited to, orthopedic implants for spinal conditions and trauma, abdominal and breast repairs/reconstruction implants, general science materials, disease states awareness for cardiovascular conditions and neurological diseases, diagnostic drug or agents used in radiology and molecular imaging. and injector are met. Objectively collaborates across the organizations and with strategic alliances and key agencies to stay well-informed in the areas of US medical guidelines, emerging trends, and regulatory requirements, intelligence developments, and compliance.
Lin Wu’s Current Industry Supernus Pharmaceuticals
Lin
Wu’s Prior Industry
Medtronic
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Fresenius Medical Care North America
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Depuy Synthes Companies
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Treximo
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Ge Healthcare
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Supernus Pharmaceuticals
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Work Experience

Supernus Pharmaceuticals
Associate Director, Commercial Regulatory Affairs
Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Ge Healthcare
Review Leader, Advertising and Promotion, Regulatory Affairs
Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Treximo
Consultant, Regulatory Affairs
Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Depuy Synthes Companies
Manager, Regulatory Affairs
Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Fresenius Medical Care North America
Principal Associate, Regulatory Affairs
Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Medtronic
Specialist, Regulatory Affairs
Thu Jan 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)