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  • Regulatory Affairs Consultant
    Regulatory Affairs Consultant
    8 days ago
    Full-time
    Hartsdale

    JOB SUMMARY: We are seeking an experienced Regulatory Affairs Consultant to provide expert guidance on compliance, documentation, and regulatory strategy. The consultant will support product registrations, regulatory submissions, audits, and ensure adherence to all applicable local, federal, and industry regulations. KEY RESPONSIBILITIES: Develop and implement regulatory strategies to support product approvals and compliance. Prepare, review, and submit regulatory documents, reports, and technical files. Ensure products meet regulatory requirements across relevant markets. Advise on regulatory changes, updates, and potential business impacts. Coordinate with internal teams to ensure documentation accuracy and readiness for audits. Communicate with regulatory agencies as needed for approvals or clarifications. Conduct compliance assessments and recommend corrective actions. Maintain detailed records of submissions, approvals, and regulatory correspondence. QUALIFICATIONS: Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, Biotechnology, or related field. Proven experience in regulatory affairs within relevant industry (e.g., pharmaceuticals, medical devices, cosmetics, food, etc.). Strong knowledge of regulatory standards and submission processes. Excellent analytical, documentation, and communication skills. Ability to manage multiple projects and deliver within deadlines. PREFERRED SKILLS: Experience with FDA, EMA, or local regulatory authorities. Familiarity with quality management systems (ISO standards). Strong attention to detail and problem-solving skills. WORK SETUP: Contract / Consultant Remote or On-site depending on project needs

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  • Education Specialist
    Education Specialist
    1 month ago
    $24–$27 hourly
    Full-time
    Forest Hills, Queens

    We are seeking an Education Specialist to support the Queens Childcare Network (QCCN). The primary role of the Education Specialist is to build strengths-based relationships within our network of licensed in-home childcare providers. This role focuses on guiding and supporting our family or group family daycare providers by coaching them on play-based instruction in accordance with Department of Education (DOE) curriculum. PRIMARY RESPONSIBILITIES: • Serve on a team supporting a network of regulated in-home childcare providers serving 500+ children ranging in infancy to 12 years of age., • Assist in the launching of a new NYC DOE contract for the EarlyLearn and 3K Programs., • Provide effective guidance to ensure effective services to QCH's 45+ affiliated family and group family childcare providers., • Collaborate with the QCCN Education Director, Family Support Worker, and Health Monitors to meet the needs of all children and families., • Provide twice monthly strength-based practice-based coaching to up to 17 affiliated providers as they implement a mixed-age curriculum., • Adapt and provide guidance to affiliated providers on the implementation of an evidence-based curriculum for mixed-age group settings that meets the individual needs of all children., • Review and adapt appropriate curriculum with affiliated providers that foster hands-on developmentally appropriate and relationship-based interactions with all children., • Assist affiliated providers gathering observations of children and entering child assessment data in a timely manner and support its use for curriculum and lesson planning., • Document all coaching sessions aligned with the DOE’s Early Childhood Framework for Quality (EFQ)., • Assist in ongoing outreach, enrollment, and all other administrative tasks., • Support QCCN Education Director in coordinating all required professional learning days throughout the year., • Maintain relationships with community partners who provide mental health, special needs, and other support services for all affiliated providers and families., • Participate in weekly Network team meetings and applicable NYC DOE Trainings and Meetings., • Assist in the facilitation of monthly Network Professional Learning/Development sessions., • BA/BS in Early Childhood or Infant/Toddler Studies; Master’s degree preferred; Comparable Social Work, Psychology or Human Service education also accepted;, • Bilingual English/Spanish: verbal, reading & written fluency (preferred);, • Computer literate: Microsoft Word, Excel, & Teams; and Zoom (required);, • Experience teaching or serving children under age 5 (required);, • As indicated, ability to work effectively from home or another remote location with consistent Wifi, privacy and utilization of agency communication and learning tools (required);, • As indicated, ability to efficiently travel within QCH Network (Queens, NY) catchment area and conduct on site coaching sessions at designated in-home daycares (required);, • Exceptional time management skills; Ability to multitask; Must be a team player (required);, • Cultural sensitivity; Respect for the unique backgrounds of all QCCN providers and families (required);

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