Regional Product Stewardship and Regulatory Specialist

[Company Description]
Global Chemicals Company

[Responsibilities]
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.


Coaching/Mentoring

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

[Requirements]

  • 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

[Salary]
8~13M

[Location]
Tokyo

[Welfare]
Social insurance

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


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We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.