Regulatory Chemist

Description

Regulator Chemist

Location : Chennai, India

Required Language : English

Employment Type : Full-Time

Seniority Level : Associate

Travel Mode : Moderate

About Us

Buckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining safety in the workplace, and promoting sustainable development. Buckman works proactively and collaboratively with its worldwide customers in pulp, paper, leather, and water treatment to deliver exceptional service and innovative specialty chemical solutions to help boost productivity, reduce risk, improve product quality, and provide a measurable return on investment. Buckman is in the middle of a digital transformation of its businesses and is focused on building the capabilities and tools in support this.

Purpose

The mission of the Regulatory Chemist Specialist (RAS) is to prepare and file demands for regulatory approval of the products of the company by preparing, coordinating, and supervising regulatory submissions and reviewing product conformance and assure compliance, Implementing different strategies in order to meet evolving regulatory initiatives, register products according to provincial guidelines and regulations of third party suppliers Keep current with regulations Participate in conferences and interdepartmental meetings.

Qualifications & Experience

 Degree in Chemistry / Microbiology or analytical chemistry discipline or relevant discipline.

 Regulatory experience in Chemical industry

 Understand Halal, Kosher requirement and application process

 Familiar with REACH, FDA, GHS guidelines

 Good document management skill and willing to spend more time on paper work

 Experience with Asia Pacific regulatory processes and bodies

 Detail-oriented and intrinsically motivated

 Skilled user of Microsoft Office 365. knowledge on Intelligent Authoring will be a plus.

Accountabilities

 Issue regulation compliance letter to the customer promptly and accurately when required.

 Providing product-related regulatory information and knowledge to the stakeholder to make sure 100% compliance.

 Obtain regulation information from the supplier

 Maintain and update the regulation database

 Assess regulatory requirements and develop regulatory strategies for the qualifications of new products in ASEAN, Australia, and New Zealand.

 Compile technical files, test reports and documentations necessary for regulatory submissions.

 Maintain up to date documentation and archival regulatory submissions and related documents according to the company's documentation policies and procedures.

 Work with the global regulatory affairs group and manage areas of regulatory risk to core business activities in Asia.

 Maintain up-to-date knowledge and information related to product regulation.

 Understand the product registration requirement in Asia countries and manage the product registration when required.

 Stay updated on industry regulations, policies, trends, and opportunities by participating in industry associations and conferences.

 Generate product SDS and make sure the SDS is up to date to the regulation requirement.

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Skills Required

Experience with Asia Pacific regulatory processes and bodies, Skilled user of Microsoft Office 365, Knowledge on Intelligent Authoring, Understand Halal Kosher requirement and application process, Familiar with REACH FDA GHS guidelines, Regulatory experience in Chemical industry