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Restricted Substances Specialist

Planet Pharma Group

Target Compensation Target PR Range: 35-45/hr Depending on experience Background The Restricted Substances Management (RSM) function is responsible for compliance with country-specific chemical regulations impacting products/components, or requiring registration of substances used in the manufacture of our products. Examples of chemical regulations are EU REACH, EU RoHS, US Conflict Minerals, China MEE No. 12, US Proposition 65, etc. Primary Function/Primary Goals/Objectives This position will be responsible for data management and activities supporting development and implementation of restricted substances management (RSM) regulatory requirements such as EU REACH, US Conflict Minerals, US Prop. 65, EU Restriction of Hazardous Substances (RoHS), etc. Responsibilities Reviews and analyzes component and sub-assembly information, assessing for restricted substances impact Works collaboratively with appropriate organizations to facilitate RSM implementation and compliance through the communication of RSM issues and development of process and tools Independently organizes, develops, implements, and manages assigned aspects of existing and novel RSM chemical regulatory projects. This includes outlining scope, time and resource management, communications, and risk mitigation throughout the project Assigned aspects include interpreting regulatory requirements, creating an actionable business process, implementing the process, and demonstrating necessary compliance. Handles several small to medium size projects in parallel and/or assists on larger projects Develops, tracks, and communicates progress against program milestones and deliverables Interacts internally, across multiple functional areas, and externally, with suppliers and third-party manufacturers, to obtain restricted substances supporting data to support business and regulatory needs. Data must be well-organized and stored within existing systems. Qualifications Bachelor’s degree, preferably in science or technical-related field Knowledge or experience in areas such as manufacturing, quality, engineering, supply chain, and/or chemical regulations Demonstrated initiative and excellent communication skills Strong analytical skills Must appropriately handle confidential information Self-starter able to work with minimal supervision; results oriented; strong ability to organize workload and demonstrate problem-solving skills Desirable: Knowledge of today’s key global restricted substances regulations (e.g. EU RoHS, EU REACH); familiarity with pharmaceutical R&D, pharma manufacturing/TPM, and supply chain activities Demonstrated team player with ability to work collaboratively with RSM team and functional counterparts in a global environment; ability to influence and solicit cooperation (internally and externally) to meet program objectives Familiar with SAP and (desirable) familiarity with ARENA Competency with Microsoft software suite (e.g. PowerPoint, MS Word, Excel, Outlook) #J-18808-Ljbffr Planet Pharma Group

Vacancy posted 3 days ago
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