Senior Regulatory Affairs Manager,Asia Pacific(职位编号：002)
上海漫趣网络科技有限公司
- 公司规模：少于50人
- 公司性质：合资(欧美)
- 公司行业：中介服务 专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2013-01-09
- 工作地点：上海-浦东新区
- 招聘人数：1
- 工作经验：八年以上
- 学历要求：本科
- 职位类别：生物工程/生物制药 医药技术研发管理人员
职位描述
Job Description
Senior Regulatory Affairs Manager, Asia Pacific
We are currently seeking an outstanding Senior Regulatory Affairs Manager to join our team in China or Singapore. The position reports to the Global Regulatory Leader for Industrial Biosciences.
The primary responsibilities for this position include:
Manage regulatory clearance and/or compliance in Asia Pacific for enzymes and other industrial bioscience products for multiple, complex, and strategically important areas and serve as focal point for information on same
Monitor food and animal feed regulations, evaluate regulatory implications of product and process changes, and recommend compliance actions.
Regularly interact with and educate regulatory agencies and trade associations to achieve clearance and positively influence regulations in development and represent and promote GCOR in trade/NGO associations.
Responsible for communication of regulatory strategies and policies and developing implementation strategies and SOPs.
Evaluate regulatory implications of product and process changes and make recommendations for approval/disapproval and signs-off, as assigned.
Serve as internal regulatory consultant.
Represent department in projects, product development teams, and regional business meetings to advise on regulatory implications of options and regulatory paths for product clearance
Answers complex internal and external questions or inquiries, initiates discussions to identify solutions.
Manage/supervise junior staff
Requirements:
· BS/MS in life sciences or related field and 8+ years experience in (biotechnology) regulatory affairs or related areas or PhD with 4+ years experience.
· Knowledge of regulatory requirements to gain approval of food and feed additives in main markets in Asia Pacific. Knowledge of scientific methods in R&D and Quality.
· Proven track record of successful submissions and of influencing regulations/regulators
· Successfully impacted product introduction by providing regulatory guidance and/or successfully influenced decisions at plants to implement change
· Successfully analyzed problems with require an in-depth understanding of the organization (problems often occurred simultaneously and needed prioritization)
· Consistent proactive attitude towards clients' issues and track record of team leadership.
· Excellent skills in influencing and supporting others
· Abstract conceptualization, problem solving, and critical thinking skills
· Excellent planning, organizational and communication skills.
· Ability to function in multidisciplinary and virtual environment.
· Ability to interpret guidelines and regulations applicable to IB products.
· Ability to communicate in English (verbally and in writing), Portuguese, and Spanish. Competency in computer/software tools needed for job.
- To lead and manage the market intelligence and analysis to support business requirements across Asia
- To support the development of the leadership presentations in a manner of timely, professional, and outstanding quality
- To support business review and management meetings, including AOP review
- To support the preparation and development of regional strategic planning (STRAP) to achieve growth and profitability objectives.
- To study, analyze and recommend new business opportunities, in terms of new technologies, new markets, customers, business models, and acquisitions, etc..
- Proactively support BD candidates assessment, pipeline development, candidate/partner relationship, business case inpu, and the review materials development
- To facilitate new business planning,Strategic Growth Analysis and Support of Business Plan Development