REGULATORY COORDINATOR

Job Description

Job Specification Regulatory Coordinator Location Ranjangaon, Pune (Maharashtra) General Summary The Coordinator/Specialist Regulatory will support in the development, implementation and maintenance of the Regulatory information systems and provide overall support to the Regulatory team.Assist in the development, implementation and maintenance of the Product Stewardship management and information systems (including SAP EH&S modules on Product Safety, Dangerous Goods, etc). Support information systems implementation. Consider the business requirements, provide feedback, interpretation and training to end-users and update the system as required. ESSENTIAL DUTIES, RESPONSIBILITIES & AUTHORITIES:-

• Creation and management of regulatory documents required by the customers or some official organisms in order to start or to continue the commercialization of finished goods.
• Contacts with the raw materials suppliers in order to obtain the documents (= certificates & regulatory documents) needed to rule on the conformity of the finished goods.
• Preparing and editing of finished goods material safety data sheets.
• Responsibility of the edition of certificates in conformity with different legislations (food contact, packaging, list of forbidden chemical substances, etc.)
• Work closely with Sales, Technology, Supply chain, CSR and PSRA colleagues to prioritize activities.
• Using tools within the SAP EH&S Module, provide data for various reports. Develop and maintain MSDS for the non-prime materials and other manually produced MSDS.
• Provide assistance in developing, implementing and maintaining Product Stewardship/Regulatory standards for new product development, review Product Stewardship procedures for plants and business groups, and provide interpretation and training to end-users. Create documentation of internal processes and procedures.
• Understand pertinent product regulations and interconnection with company systems to ensure compliance.
• Assist in evaluating compliance with Product Stewardship standards and applicable laws and regulations. Assist in identifying and maintaining new requirements, provide information to business units and plants to elevate awareness, work with consultants and law firms.
• Maintain the Product Stewardship systems current, update for changes, and provide consulting, interpretation and training on system updates.
• Work with Business Units to respond to customer inquiries regarding products and regulatory systems/information.
• Other projects/duties as assigned or needed.
• Responsible for creating and updating compliant Safety Data Sheets in multiple country and regional regulatory formats through the use of in-house software (SAP).
• Contacts with the raw materials suppliers in order to obtain the documents (= certificates & regulatory documents) needed to rule on the conformity of the finished goods.
• Review raw material documentation and maintain master data for use on raw materials, labels, etc.
• Work with global regulations (GHS, CLP, etc.) related to Hazard Communication.
• Work closely with Sales, Technology, Supply chain, CSR and PSRA colleagues to prioritize activities.
• Report to regional PSRA leader for Product Safety and Hazard Communication.

QUALIFICATION & OTHER SKILLS, COMPETENCIES REQUIRED:

• Bachelor or master s degree in chemistry, environmental science, biological sciences, toxicology, industrial hygiene or related technical field with minimum 3 year of experience in Regulatory, Industry or University.
• General understanding of hazard communication requirements along with experience in reviewing, reading and understanding of Safety Data Sheets.
• Team-player with strong interpersonal and customer service skills
• Good written and verbal communication skills
• Experience with Microsoft Excel, Word, PowerPoint and SAP are preferable
• Self-motivated, with excellent attention to detail and quick learning abilities
• MSDS - REACH & CLP
• Food Contact Regulations - USFDA 21 CFR, European Regulation No 1935/2004, No 2023/2006 and European Resolution AP(89)1
• Packaging Regulations - CONEG, 94/62/EC
• Automotive Regulations - RoHS, ELV, WEEE, IMDS
• California Proposition 65

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Keyskills :
product safetyfinished goodsbusiness unitssupply chainmicrosoft excel21 cfrnew product developmentmaster dataraw materialsdata sheets