Regional, Regulatory and Compliance Specialist
1 day ago
**Location**
Singapore, Central Singapore
**Job Type**
Full Time
**Salary**
$4,000 - $6,000 Per Month
**Date Posted**
1 hour ago
Additional Details
**Job ID**
5328
**Job Views**
1
**Job Description**:
Roles & Responsibilities
Position Summary:
The Regional Regulatory and Compliance Manager is responsible for effectively managing Dymax’s product regulatory programs regionally (Asia) in support of our Singapore and Korean offices. Responsibilities include assisting in the implementation of corporate product regulatory standards, procedures, systems, and processes, and ensuring global compliance and business support in the Asian region. The incumbent will manage and coordinate new chemical and product registrations, monitor importation of chemicals and quantities regionally that effect volume reporting and usage, and assist with evaluating new business growth through compliance management. The individual will have in-depth knowledge of the chemical industry and manufacturing and will remain current of worldwide chemical regulations and standards including, but not limited to GHS, TSCA, EU REACH, CLP and KOREA REACH. The incumbent will also need to demonstrate prior product stewardship and/or regulatory compliance, Dangerous Goods classification, and Safety Data Sheet (SDS) authoring experience. The position will coordinate activities, budgets, define timing and prepare submissions related to the management of chemical issues, chemical inventory listings and registrations.
**Responsibilities**:
Manage and support the notification and registration of substances and products to regional or country inventories, including the coordination and preparation of regulatory submissions to various government agencies or consultants.
Author SDSs/label documents for Dymax products in region and globally if needed.
Provide regulatory assessments for proposed business and manufacturing changes related to approved products in compliance with guidelines and regulations of those countries that Dymax sells into.
Provide regulatory and compliance assistance during regional manufacturing site inspections.
Utilize company approved tools and systems to manage regional regulatory issues, including enterprise system and regulatory/SDS authoring and label creation software. (Dymax uses WERCS software)
Review, advise and assist with preparing domestic and international labels, package inserts, etc. based on applicable regulations and approved platform labels, in cooperation with Business Operations, and Supply Chain.
Serve as a member of interdepartmental working groups providing regulatory expertise for assigned projects or segments of projects related to approved products.
Maintain an awareness of regulatory issues and current possible developments in assigned geographic and technical areas.
Assist in the development and implementation of regulatory strategies necessary to: (1) optimize the position of Dymax products in the market by regulatory means; (2) implement manufacturing strategies; and (3) maintain the products throughout the lifecycle in line with company direction and agreed priorities including routine regulatory activities and considering the possible future evolution of the regulatory environment.
Ensure regulatory compliance of licensed Dymax products throughout their lifecycle, ensuring proper regulatory management of changes, deviations, exemptions, notifications, etc. in close collaboration with Operations, Quality Assurance, R&D, Business Operations, and others.
Preparing and submitting core regulatory documents for product renewals, variations, country extensions, etc., as assigned.
Communicate with customers to provide regulatory compliance information (e.g., restrictive substances and global inventory status) and respond to compliance request related to Dymax products.
Maintain tools (records, schedules, reports, database, etc.) for timely management of regulatory activities.
**Skills/Qualifications**:
Bachelor’s Degree or equivalent in chemistry, regulatory or similar discipline
3 to 5 years’ experience in similar, global chemical manufacturing or formulating company role, managing similar systems and data.
A strong database experience (Access, Excel, JDE E1) to set up functions, enter data or process information. Experience with The WERCS software highly preferred.
Sound knowledge of the regulatory requirements and legal framework for products and industry trends in the Asian Region.
Strong interpersonal, presentation and verbal communication skills.
Tags
regional
regulatory
and
compliance
specialist
singapore
korea
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