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MG-Regulatory Affairs(生物技術)

描述

Job Description:

-Develop registration strategy and plan by working with local regulatory manager, global regulatory manager and regulatory science team to secure agreed milestones and timely regulatory approvals for biotech seeds.

-Compile and develop high-quality submission dossiers and technical responses which excel standards required by authorities and industry; manage paper and digital documentation of regulatory documents to meet relevant compliance requirements.

-Collect intelligence relevant to local biotech regulations; provide timely impact analysis on registration timeline, data requirements, study design and costs…etc. and communicate with global colleagues to ensure regulatory studies generated in a timely and qualified manner.

-Establish and maintain good working relationship with key regulatory agencies to ensure effective bilateral communication channels established.

-Lead and execute industry’s initiatives in driving regulatory changes toward science-based globally harmonized system and promoting favorable regulatory environment for biotech seeds.

-Collaborate across local industry associations and stakeholders of value chain on global and local priority regulatory issues and ensure company is represented to contribute in conveying globally or regionally approved messages to government, academics, industry and local management in response to relevant regulatory development.

Requirement:

-Education: MS in molecular biology, plant biotechnology, biochemistry or related field.

-Working Experience: 4+ years working experience in regulatory affairs or biotech-related industry.

-Technical & Professional Knowledge: scientific knowledge/experience in modern biotechnology studies (e.g. gene editing, NGS, ddPCR, mass spectrometry, marker-assisted selection…etc.) and/or toxicology studies (e.g. animal feeding studies…etc.).

-General Knowledge of the regulatory procedures, registration processes, data requirement for registration and regulatory authority constraints.

-Understanding of plant biotechnology issues and their social significance.

-Great command of English and Chinese, both written and spoken; ability to read and communicate in Japanese is a plus.

-Excellent professional skills in organization, planning, project execution, scientific writing and/or presentation.

-Good people skills in listening, communication, empathy, understanding objections and/or problem solving.

-Flexibility in working hours (i.e. night conference calls; 19:00~23:30).

-General Knowledge of the regulatory procedures, registration processes, data requirement for registration and regulatory authority constraints


產業

其他


專業領域

其他
醫療保健/生命科學/生物/製藥產業


位置

台北市


雇用類型

全職


薪水

月薪


若您符合此職缺的條件,請寄完整履歷至 Meg Yen.
電子郵件: meg@recruitexpress.com.tw
電話: 0287806811
*立可會嚴格保護您所有資訊。我們僅與資格符合的候選人聯繫


If you meet the requirements of this role, please email a detailed resume in Word document to Meg Yen.
Email: meg@recruitexpress.com.tw
Tel: 0287806811
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.