月薪38000~55000元 台北市中山區 1年工作經驗 4天前更新
Job Title:
Regulatory Registration Affairs
Job Description:
• Develop registration plan by working with regulatory manager 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 communication
• Support regulatory manager to execute the industry’s initiatives in driving regulatory changes toward science-based globally harmonized system for biotech seeds
• Support regulatory manager to 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:
• Master or above in Biotechnology or Biology related field, preferably Molecular Biology and Biochemistry, with at least 3 years of relevant experience
• 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
• Proficient in English and Chinese, both written and spoken
• Good skills in organization, planning, project execution and presentation
• Good interpersonal skill including listening, communication, empathy, understanding objections and problem solving
• Flexibility in working hours (i.e. potential conference calls at night)
福利:
1.年假10天/彈性假7天/帶薪病假30天
2.年度績效獎金
3. 免費的團體保險,保障員工的工作權益
展開 產假全勤獎金員工生日禮金年終獎金激勵獎金