Regulatory Affairs Specialist

KETJEN is seeking a Regulatory Affairs Specialist for our Asia-Pacific geography to join our global Product Stewardship team to work with a team of regulatory professionals located around the world to maintain a robust global registration, compliance and hazard communication program for Ketjen’s full product portfolio, with a primary focus on the Asia Pacific region (China, Korea, Indonesia, Japan, India, Vietnam, Malaysia, etc.). This role will report to the Ketjen Global Product Stewardship Leader.

JOB RESPONSIBILITIES

• Provide overall regulatory support, including developing regulatory strategies and timeline development, and prepare, submit and maintain chemical management regulatory filings (including renewals) to ensure compliance with country regulations, with a primary focus on Asia Pacific regional countries of business interest to Ketjen.
• Assess current products to ensure they are in compliance with applicable regulations
• Develop internal network with Product development, HS&E, Regulatory, Commercial Sales, Technical Support, and Procurement/Logistics business partners as required to support compliance activities
• Provide internal and external customer support related to registration activities, working collaboratively to develop and implement robust regulatory strategies
• Participate in cross functional product development and commercialization teams as needed, providing guidance on global regulatory requirements and strategies
• Coordinate and review product testing, where required, as performed by internal partners or external consultants to ensure regulatory and safety compliance and complete required regulatory submissions, in partnership with the Product Steward
• Contribute to the development and implementation of effective documentation and data control management for compliance files including maintaining registration files and supporting information in relevant IT systems for inquiries and historical purposes.
• Execute hazard communication for all products in APAC region, including preparation of Safety Data Sheet (SDS) and labels in the SAP-EHS system. This can involve supporting the shipment of non-commercial sample quantities into the Asia-Pacific region from the Ketjen businesses.

• Execute external consultant relationships on issues requiring expertise not found in Ketjen, including authoring contracts for approval by Purchasing, and handling payments/invoicing, and budget projections for such services.
• Support other Albemarle’s Product Stewardship activities as appropriate and directed, including providing backup support within the Ketjen Product Stewardship team to provide sufficient 24 hour coverage of urgent Ketjen requests, as well as to coordinate global work as needed with peer partners in US and European regional time zones.

TYPICAL JOB DUTIES

• Prepare and coordinate regulatory submissions in accordance with Ketjen policies and procedures on a world-wide basis, consistent with local regulations and requirements.
• Interpret, where appropriate, various global chemical regulations in conjunction with other global product stewardship staff, maintaining a proactive awareness of APAC country regulations and pending regulatory developments relating to product sales.
• Interface with internal (typically Sales, Technical Service, Procurement and Supply Chain/Logistics) partners, as well as external customers to provide additional information or guidance on the various regulatory and compliance needs in the specific regions and coordinates and executes the registration strategy as agreed.
• Work on various assignments to help implement and maintain procedures and programs to support existing markets globally to ensure permanent product compliance, with a focus on Asia Pacific regional countries, including some administrative and operational tasks.
• Support updates of our enterprise software (SAP GTS module) with corporate IT to reflect trade compliance limits, flags, and updated Safety Data Sheet content, in partnership with teammates in the Product Stewardship team.
   

REQUIRED QUALIFICATIONS

• Bachelor’s Degree or above with major in Chemistry, Biology, Environmental Science or other related scientific discipline
• Excellent English communication skills (written, verbal and presentation)
• 3+ years relevant experience in preparing and executing regulatory submissions on a national and international level
• Ability to understand and interpret technical and regulatory documents to ensure high quality and comprehensive regulatory submissions
• Fluency in language of country of work and residence
• Ability to travel and secure a travel visa as necessary
   

PREFERRED QUALIFICATIONS

• Regulatory Affairs Certification (RAC) or equivalent strongly desired
• Experience with Korean chemical management (K-REACH) programs and registration activities required, knowledge of other regional programs (such as Australia AICIS, New Zealand NZIoC, US TSCA, etc) a strong plus
• Experience with China product registration requirements
• Experience with Chinese, Korean, and Japanese MSDS registration and submission
• Experience with 3E ERC+ software, and SAP HSE and GTS modules