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Regulatory Affairs Specialist

Company: The Chatham Group
Location: Bloomington
Posted on: November 14, 2021

Job Description:

Our client, a leader in specialty chemistries is seeking a Qualification Specialist to ensure compliance with good manufacturing practices and regulatory requirements such as EU Cosmetics Regulation, Ecolabel, etc--- Thorough understanding of applicable Regulatory and Industry requirements, standards, and guidance such as IPEC, ISO, FDA, EMA, TGA, ICH, and PIC/s.
PRIMARY JOB FUNCTIONS:

  • Works with sales team and customers to accelerate conversion to clients' products
  • Engages directly with customers to understand must have quality assurance/regulatory requirements
  • Segments customers according to product quality assurance/regulatory requirements
  • Educates customer/commercial on tangible product quality assurance requirements for product application
    PRIMARY JOB FUNCTIONS & PROFESSIONAL ACUMEN:
    • Computer System Proficiency: among other things, SAP and EXCEL, PowerPoint.
    • Leads quality discussions between customer, commercial, and quality/regulatory groups to ensure alignment and full understanding of customer quality assurance requirements
    • Resolves customer quality assurance queries, recommend, and guide the appropriate options
    • Create customer segments, develop, and implement quality assurance/regulatory requirements aligned to customer segmentation
    • Participates and serves as customer liaison during audits
    • Excellent communication skills that earn the trust of the customer and the commercial team, is a trusted partner for educating each on the relevant quality assurance requirements
    • A high degree of confidence to be able to say no to options that do not align with customer segmentation or requirements
    • Establishes our reputation as a company that offers excellent customer support during the product qualification process
    • Works effectively and fosters a collaborative environment across the global teams to share knowledge, seek input to issues and develop shared accountability for meeting functional goals.
      ROLES AND RESPONSIBILITIES DETAILS:
      • Establish contact with their peers in our customers Quality organizations
      • Respond to product qualification inquiries in a timely and accurate way, via phone, email, or in-person meetings
      • Assist customers with the product qualification process
      • Analyze and report any new or emerging customer needs as it relates to product quality assurance (e.g., different test methods, impurity profiles, etc.)
      • Update internal databases with information about product quality assurance issues and ensure timely responses back to the customer
      • Gather customer feedback and share with Commercial, Quality, and Regulatory teams
      • Regulatory
      • Understands basic regulatory requirements for the region for each market segment and collaborates with business teams to support market expansions and new product introductions (product qualifications)
      • Liaison with Regulatory to always have access to updated product literature related to regulatory compliance/claims
      • Properly manages priorities according to deadlines
      • Quality
      • Working knowledge of applicable Regulatory and Industry requirements, standards, and guidance such as IPEC, ISO, FDA, EMA, TGA, ICH, and PIC/s.
      • Establishes quality assurance standards by studying product and customer requirements with members of commercial and quality functions.
      • Actively assists in investigations into product-quality failure or non-compliance.
      • Effectively partners with QA managers in order to implement corrective and preventative actions.
      • Analyzes customers' product specifications to establish efficient, cost-effective requirements for reproducibility
      • NA Regulatory Coordinator
      • Works in partnership with the Responsible Care Team to execute corporate Responsible Care initiatives
      • Maintains and tracks progress against the Product Stewardship Plan.
      • Evaluates and modifies key performance indicators (KPIs) as needed
      • Supports root-cause analysis and other problem-solving activities to identify corrective actions and process improvements.
      • Initiates and implements product quality improvement activities as appropriate to raise adoption
        QUALIFICATIONS :Customer Qualifications Specialist(s) have:
        • A Bachelor preferred, or education coupled with quality/regulatory certifications
        • Experience with & understanding of Quality Management in the chemical and/or life sciences industry
        • Two-five years of experience is desired.
        • Previous work experience with chemical management regulatory bodies.
        • Employers are seeking candidates who possess the following skills:
        • Ability to set priorities and work independently.
        • Ability to work concurrently and manage multiple projects.
        • Ability to work in a team environment.
        • Analytical, problem solving, and synthesis skills.
        • Flexibility and diplomacy in interpersonal relationships.
        • Fluency in English (written and spoken).
        • Proficiency in the use of common and specialized software.
        • Ability to meet deadlines.
        • Strong Communication skills.
        • Ability to grasp new strategies and pathways

Keywords: The Chatham Group, Bloomington , Regulatory Affairs Specialist, Other , Bloomington, Illinois

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