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regnyly

Yan-L

@regnyly

Professional Pharmaceutical Translator

Cina
Inglese, Cinese
Alcune informazioni sono riportate in lingua inglese.
Chi sono
I am a bilingual English–Chinese translator and pharmaceutical professional with 20+ years of industry experience, including senior quality and compliance roles at leading U.S. pharmaceutical companies. I specialize in pharmaceutical, biotechnology, GMP, regulatory, quality, and technical document translation. I also provide professional translation services for business correspondence, reports, presentations, websites, and general documents. Accurate, reliable, and culturally appropriate translations guaranteed.... Continua a leggere

Competenze

r
regnyly
Yan-L
offline • 
Tempo di risposta medio: 1 ora

Consulta i miei servizi

Traduzione
I will translate pharmaceutical, gmp, regulatory, and technical documents

Esperienza lavorativa

Director of Project Management

Shanghai Bao Pharmaceuticals Co., Ltd.

Sep 2024 - Present1 yr 10 mos

• Direct Interpretation Experience: Served as a key interface for external cooperation, leading and providing full-scope on-site interpretation for multiple international client audits, business negotiations, and technical exchanges. Ensured accurate, professional real-time bilingual conversion in dialogues involving complex technical details (e.g., process validation, quality control) and commercial terms (e.g., License-out agreements), guaranteeing zero miscommunication. • Written Translation & Proofreading Experience: Responsible for language polishing, proofreading, and terminology consistency review of company's English submission documents, ensuring compliance with international submission language standards and professional norms.

Director of Quality Control

iCamuno Biotherapeutics Inc.

Mar 2023 - Aug 20241 yr 5 mos

Established a QC system from scratch that met both Chinese and international requirements. Led the drafting, review, and finalization of a large volume of core documents in both Chinese and English (parallel or standalone versions), including quality manuals, SOPs, validation protocols/reports, etc. This experience represents concentrated practice in precise bilingual construction of professional content.

Quality Manager / QC Scientist III-IV

Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA

Nov 2009 - Mar 202313 yrs 4 mos

• Foundation in English-Only Professional Environment: Over 13 years in core quality departments of a top global biopharmaceutical company with 100% English as the working language. Progressed from technical roles to management, deeply involved in and leading the full English communication cycle for dozens of projects. • High-Intensity Verbal Practice in Management Role: As Quality Manager, daily activities included: leading cross-functional project meetings, reporting to senior management, conducting team meetings, participating in Q&A during FDA and other agency inspections, and holding technical teleconferences with CROs. This accumulated extensive experience in real-time professional verbal expression and adaptability in specialized scenarios. • Author and Reviewer of High-Level Written English: Core responsibilities included authoring, reviewing, and approving various critical English documents such as IND/BLA submission sections, integrated clinical study reports, complex SOPs, and audit responses. Developed an almost instinctive grasp of the style, grammar, and terminology of academic, regulatory, and managerial English.