1、Deliver innovative and beneficial consumer drug products regulatorystrategy in a timely manner.
2、Strategic leadership of consumer drug product development andNPD/MPR registration projects to meet the business objectives for the business.
3、Straight to point communication with stakeholders, such as: Plant,Regional, HQ, MKT, R&D, Med, Toxicity, Clinical Operation, GCMC etc.
4、Full compliance with all government regulations and corporatepolicies including oversight of corrective actions.
5、Coordination and implementation of consistent standards andprocesses, as well as sharing of best practices across the PCH regulatoryorganization.
6、Direct the growth and professional development of the RA teammembers.
7、Manage the regulatory professionals ensuring high qualitydeliverables against their objectives
8、Accountability for capacity and capability management.
9、Development of working/partnering relationships with key agencies inthe business.
10、Timely submission of regulatory applications for new productregistrations.
11、Be a recognized as a key partner for local business activities andinitiatives, including licensing opportunity considerations, innovativeregulatory strategies, and talent management.
Technical Skill Requirements
1、Good technology of CMC, preclinical, clinical.
2、Understanding of regulatory agency philosophies and guidelines.Capture regulatory trend to reflect into regulatory strategy change. Experiencepreparing and submitting health product registration applications, variationsand renewals. Working with andinfluencing, opinion leaders, external organizations and facilitating approvalof innovational projects.
3、Communicates effectively using a variety of mediums appropriate tothe setting
4、Can negotiate skillfully in tough situations with both internal andexternal groups. Can be direct and forceful as well as diplomatic. Gains trustquickly of other parties to the negotiations
5、Effectively identifies issues and challenges and works with partnergroups to identify options and implement agreed solutions
6、Understands how role is impacted by and contributes to externalbusiness environment and financial drivers
7、Makes decisions in a timely manner, sometimes with incompleteinformation and under tight deadlines and pressure; able to make a quickdecision.
8、Makes good decisions based upon a mixture of analysis, wisdom,experience, and judgment; most of his/her solutions and suggestions turn out tobe correct and accurate when judged over time; sought out by others for adviceand solutions. 9、Will stand upand be counted; doesn't shirk personal responsibility; can be counted on whentimes are tough; willing to be the only champion for an idea or position; iscomfortable working alone on a tough assignment.
10、Can be counted on to exceed goals successfully; is constantly andconsistently one of the top performers; very bottom-line oriented; steadfastlypushes self and others for results.