Regulatory Service Specialist (Senior)
Apply now »Date: Sep 26, 2024
Location: Pudong New District, SH, CN, 201204
Company: Lubrizol Corporation
About Lubrizol
The Lubrizol Corporation, a Berkshire Hathaway company, is a specialty chemical company whose science delivers sustainable solutions to advance mobility, improve wellbeing and enhance modern life. Founded in 1928, Lubrizol owns and operates more than 100 manufacturing facilities, sales, and technical offices around the world and has about 8,000 employees. For more information, visit www.Lubrizol.com.
We value diversity in professional backgrounds and life experiences. By enabling a consistent, unbiased, and transparent recruitment process, Lubrizol seeks to create a positive experience for candidates so we can get to know them at their best. We recognize unique work and life situations and offer flexibility, ensuring our employees feel engaged and fulfilled in every aspect of life.
PURPOSE:
This position is to ensure Lubrizol products’ compliance with market-specific regulations for engineering polymers, personal care and home care, pharm and medical device and Lubricant oil related applications in Asia Pacific and to provide timely regulatory expertise, guidance and assistance to internal and external customers on product safety and compliance related issues that occur throughout the product lifecycle, using an approach consistent with Responsible Care® principles for assigned business units.
RESPONSIBILITIES / ACCOUNTABILITIES:
- Ensure compliance with market-specific applications in sensitive end-use applications such as personal care, food contacting, pharma, medical device, etc.
- Conduct regulatory assessment and develop registration strategy, plan and dossier preparation in support of new product initiatives and product line extensions for market specific applications in Asia Pacific
- Help drive regulatory and compliance as part of commercial strategy for existing or new product launches.
- Ensure that new product approval data requests and significant changes to product labels and SDSs are communicated in a timely manner.
- Provide internal and external customer regulatory trainings and daily regulatory supports to demonstrate our competence.
- Monitor related regulations developments in Asia Pacific and conduct advocacy as needed through active participation in trade associations/industry groups and through direct interaction with regulators in Asia Pacific.
- Integrate and maintain intimate knowledge of strategy, key chemistry and products of defined business in order to proactively identify and communicate current or future potential regulatory opportunities and threats to help Lubrizol be well prepared.
- Be a coordinator and integrator for regulatory requests for information from the region to the global business units. Be a representative of the region to global business units highlighting the requirements and needs to comply with the regulatory and compliance issues in the region.
REQUIREMENTS – EDUCATION, EXPERIENCE, SKILLS:
- Bachelor’s degree or above in Chemistry, Polymer, Toxicology, Pharmacy, Medical, or other related majors.
- At least 5+ years’ experience in product stewardship or product regulatory compliance experience in industry new chemical substance, cosmetic safety risk assessment, food contacting registration, China new cosmetic registration, China pharma excipient filing, China medical device related product registration dossier submission and working with regulators.
- Must be self-motivated and comfortable working in a team environment.
- Ability to handle multiple tasks and to work to tight deadlines and changing priorities.
- Excellent oral / written communication and interpersonal skills (Fluency in English is a must).
- Detail-oriented and results-driven.
CONSIDERED A PLUS:
- Knowledge of and experience in lubricant/coating/ink products
- Kowledge and experience in safety assessment
- Advanced degree in Chemistry, Toxicology, Pharmacy, Medical, or other related majors
- Knowledge of global chemical control laws or hazard communication requirements
- Previous experience in leading projects
- Experience in corporate ERP business systems, such as SAP
Ready for your next career step? Apply today and let's shape the future together!
It’s an exciting time to be part of Lubrizol. Lubrizol is not staying put. We are continually learning and evolving. Our passion delivers our success — not only for Lubrizol but for those who count on us every day: our employees, customers and communities.
We work with a relentless commitment to operate safely and responsibly, keeping safety, sustainability, ethics, and compliance at the forefront of everything we do. The well-being of our employees, customers and communities is paramount to our culture and in the way we approach our work.
As a diverse, global team, we work together to solve some of the world’s most pressing challenges. We impact everyday lives through science only Lubrizol can deliver, and we never stop pushing to do it better.
One of the founding principles of The Lubrizol Corporation more than 90 years ago was treating every employee with dignity and respect. That same commitment is only stronger today.
More than that, we are committed to providing an environment where every employee can be the best they can be, no matter their race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or any other characteristic.
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