Regulatory Affairs Specialist

MKS Inc.; Penang; On-site; MYR 120,000 - 240,000; Full time

Job summary

MKS Inc. seeks a Specialist Regulatory Affairs to manage global regulatory registrations and ensure compliance with international regulations. You will liaise with internal teams (R&D, Procurement, HSE, Operations) and external authorities, tracking regulatory trends and implementing joint actions.

You will also support the company’s sustainable development roadmap. You will coordinate REACH, K-REACH, KKDIK, TSCA registrations, perform raw material compliance checks, and train stakeholders on

Qualifications

• Bachelor in chemistry, toxicology or a similar field.
• Experience in Regulatory Affairs in an international chemical/pharma environment.
• Advanced knowledge of global chemicals legislation.
• Initial experience in substance-specific risk assessment.
• Strong SAP and IUCLID skills, plus MS Office usage (PowerPoint).
• Excellent spoken and written English.
• Accurate, diligent work style and reliability.

Responsibilities

• Monitor regulations, standards, government policies globally for applicability to MKS products.
• Engage with associations, consultants and authorities to define requirements and follow-up actions.
• Support sustainable development roadmap for MKS Atotech.
• Coordinate declarations (Conflict Minerals, inventory status, restrictions).
• Coordinate new chemical substance registrations globally (REACH, K-REACH, KKDIK, TSCA).
• Perform raw material compliance checks.
• Coach and train local/global stakeholders on new regulations.
• Read, understand and evaluate impact of new regulations.

Skills

Regulatory knowledge

English language

Cross-functional collaboration

Attention to detail

Regulatory trend monitoring

Education

Bachelor in chemistry/toxicology or similar

Tools

SAP

IUCLID

MS Office

PowerPoint

Job description

In your role as Specialist Regulatory Affairs (m/f/d) you are responsible for all aspects of Global Regulatory Affairs such as for the registration of substances under REACH regulations. You will assure compliance of international regulations. You will also work with internal (e. g. R&D Business, Procurement, HSE and Operations) and external experts (national and international authorities). The monitoring of the emerging regulations and trends takes place in Regulatory Affairs department, and the results are communicated within the internal departments and a joint implementation is developed. You will also support us in our sustainable development roadmap.

Your responsibilities

• Monitoring of regulations, standards, government policies and practices globally and determine applicability to MKS product
• Exchange with associations, consultant, and authorities to define requirements and follow up activities
• You support us in our sustainable development roadmap for MKS Atotech
• Support of local and global stakeholder on product specific declarations (Conflict Minerals, inventory status, restrictions etc.).
• Coordination of new Chemical substance registrations globally (REACH, K-REACH, KKDIK, TSCA etc.)
• Raw material compliance check
• You will be coaching and training local and global stakeholder regarding new regulations
• Read, understand, and evaluate the impact of new regulations

Your skills and competences

• You have successfully completed bachelor’s degree in chemistry, toxicology or similar
• Working experience in the field of Regulatory Affairs in an international environment in chemical/pharmaceutical industry
• You have an advanced professional knowledge of global chemicals legislation
• You have initial experience in substance specific risk assessment
• Strong user knowledge of SAP and IUCLID skills, as well as MS Office (especially PowerPoint)
• Excellent spoken and written language skills in English
• Accurate and responsible work style as well as high degree of diligence and reliability