Regional Product Stewardship and Regulatory Specialist

[Company Description]
Global Chemicals Company

Summary of the position: Provide Product Stewardship and Regulatory support and coordinate the regional/global response to healthcare/regulated applications-related customer inquiries & documentation for Performance Polymers Products lines. Provide coaching on regulatory aspects for other regional team members.

Key Contact for our 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.
  • 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.


  • Provide coaching and mentoring for other employees of regulations and work processes & Identify opportunities for personal development and escalate to manager.


  • 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.

[Employment Type]
Full time



Social insurance

Full 2 holiday week system (Sat/Sun) national holidays
New year's holiday
Annual Leave

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