Regulatory Affairs Specialist

MKS Instruments; Batu Kawan; On-site; MYR 90,000 - 150,000; Full time

Job summary

MKS Instruments in Penang, Malaysia seeks a Specialist Regulatory Affairs to manage global regulatory activities for chemical registrations and compliance. You will interact with R&D, procurement, HSE and operations, and work with national and international authorities to implement regulatory changes.

You will monitor evolving regulations, support the sustainability roadmap for MKS Atotech, and train stakeholders on new requirements, ensuring timely declarations and registrations across regions.

Qualifications

• Bachelor’s degree in chemistry, toxicology or similar.
• Working experience in Regulatory Affairs in an international environment in chemical/pharmaceutical industry.
• Advanced knowledge of global chemicals legislation.
• Initial experience in substance-specific risk assessment.
• Strong user knowledge of SAP and IUCLID, plus MS Office (PowerPoint).
• Excellent spoken and written English.
• Accurate, responsible work style with high diligence and reliability.
• Desire for research.

Responsibilities

• Monitor regulations, standards, government policies globally and determine applicability to MKS products.
• Exchange with associations, consultants and authorities to define requirements and follow up activities.
• Support sustainability roadmap for MKS Atotech.
• Coordinate product 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 impacts of new regulations.

Skills

Regulatory Affairs

Global chemicals legislation

SAP

IUCLID

MS Office

English language

Risk assessment

Attention to detail

Research

Education

Bachelor’s degree in chemistry

Toxicology or related field

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
• Desire for research

#LI-DNI

Globally, our policy is to recruit individuals from wide and diverse backgrounds. However, certain positions require access to controlled goods and technologies subject to various export control regulations. Applicants for these positions may be limited (by, for example, their countries of citizenship, country of origin, or immigration status) where required by law or governmental contact, and/or employment made contingent upon the issuance of appropriate governmental licensing.

MKS Inc. and its affiliates and subsidiaries (“MKS”) is an affirmative action and equal opportunity employer: diverse candidates are encouraged to apply. We win as a team and are committed to recruiting and hiring qualified applicants regardless of race, color, national origin, sex (including pregnancy and pregnancy‑related conditions), religion, age, ancestry, physical or mental disability or handicap, marital status, membership in the uniformed services, veteran status, sexual orientation, gender identity or expression, genetic information, or any other category protected by applicable law. Hiring decisions are based on merit, qualifications and business needs. We conduct background checks and drug screens, in accordance with applicable law and company policies. MKS is generally only hiring candidates who reside in states where we are registered to do business.

MKS is committed to working with and providing reasonable accommodations to qualified individuals with disabilities. If you need a reasonable accommodation during the application or interview process due to a disability, please contact us at: [e-mail].

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