Regional Product Stewardship&Regulatory Consultant
上海猎英人才服务有限公司ShanghaiUpdate time: August 6,2019
Job Description
上海市

Key Contact for product compliance in the Asia Pacific Region
? Define plans to close identified compliance gaps with action plans.
? Follow up to make sure actions are taken and gaps are addressed.
Product Stewardship & Regulatory Responsibilities
? Maintain and apply knowledge of company PS&R policies, business standards/guidelines.
? Application of risk characterization, risk management and risk communication processes where required. Coordinate and facilitate regional Risk Reviews as needed.
? Actively promote the principles of sustainability and supporting Responsible Care® principles to employees & customers as appropriate.
? Participate in regional professional organizations as aligned with stewardship role as needed
? Advise business on specific product related issues.
Regulation Knowledge/Assessment
? Develop understanding of applicable regional healthcare and lubricants regulations and application of country specific policies.
? Monitor the development of regional regulations, help to provide insights and interpretation of regulations to business stakeholders.
? Provide consultation to stakeholders and clarify questions related to regional regulatory issues.
? Ensure regulatory compliances for Asia Pacific countries of all commercial activities.
? Supervision for general regulatory compliances and update compliance status in SAP.
? Assist in regional product registration activities by helping to coordinate documentation and data gathering.
? Promote sustainable (environment, health, safe handling & compliance) practices
? Participate in customer or distributor visits with commercial representatives as needed.
Innovation Support
? Develop regional registration strategy for the business, work out the appropriate approaches and communicate with Toxicology to optimize global testing requirements.
? Conduct periodic reviews of registration projects with Leveraged Support group, business TS&D, Product Managers, Product Stewards, and report to stakeholders the progress/issues. Define appropriate PS&R solutions to ensure regional product launch targets are met.
? Help to identify and communicate potential limitations for current and new business based on understanding of regulatory requirements.
? Identify the key control points and develop procedures to standardize the daily work, review with functions/individual involved to finalize procedures.
Customer support:
? Assist in answering regulatory-related customer queries for Medical and Lubricant product lines as needed.
? Work to define and implement disclosure limitations for customer inquiries and educate regional functions on defined limitations.
? Develop PS&R training materials for internal and external customers as needed.
Coaching/Mentoring
? Provide coaching and mentoring for other employees of regulations and work processes & Identify opportunities for personal development and escalate to manager.

Qualifications
? BS or MS degree in a technical field, chemistry or other equivalent background and minimum 7 – 10 years of practical product stewardship and/or regulatory experience. Proven track record of successful results.
? Excellent Japanese/English communication skills in both written and oral.
? High ethics and strong regulatory compliance awareness.
? Hands-on experience of chemical or product registration/notification in different applicable areas, preferably for medical/healthcare applications.
? Ability to interact in a positive, constructive manner and under a variety of circumstances.
? Ability to quickly and effectively build relationships, interact, and communicate information with internal and external stakeholders (network).
? Analysis & Judgment, Builds Sustainable Customer Relationships, Business Acumen, Communicating with Impact, Engagement, Innovation.
? Work independently, with excellent time management and judgment in prioritization skills.

职能类别: 专业顾问

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上班地址:上海

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