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  • Regulatory Affairs Consultant
    Regulatory Affairs Consultant
    hace 3 días
    Jornada completa
    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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  • Project Manager - Ground Up Construction
    Project Manager - Ground Up Construction
    hace 2 meses
    $130000–$145000 anual
    Jornada completa
    Hackensack

    Job Summary: We have multiple openings for Senior Project Manager, roles. These positions are responsible for overseeing wood-frame over-podium luxury residential construction projects. Based in Hackensack, New Jersey or Poughkeepsie, NY the role requires strong expertise in value engineering, budget management, adherence to strict schedules, and proficiency in construction management software such as Procore and Microsoft Project. Key Responsibilities: Project Oversight & Strategic Planning: • Oversee all project phases from initiation to completion., • Develop and execute detailed action plans, including schedules, resources, and work plans, adhering to value engineering principles Budget & Cost Control: • Ensure strict adherence to the budget through cost-saving strategies., • Monitor financials and make necessary adjustments to maintain budget alignment. Risk Management & Safety: • Identify and mitigate potential project risks., • Ensure compliance with OSHA and safety regulations specific to wood-frame over-podium construction. Negotiation & Scope Development: • Lead contract negotiations and develop scopes of work., • Respond to RFQs with detailed and competitive proposals. Stakeholder & Team Management: • Coordinate with project stakeholders and lead cross-functional teams., • Ensure effective communication and collaboration across all project phases. Schedule Management: • Maintain strict adherence to the project timeline., • Coordinate activities to avoid delays and ensure project milestones are met. Technology Proficiency: • Utilize project management tools such as Procore and Microsoft Project., • Stay up to date with relevant construction technologies. Wood-Frame Over Podium Construction Expertise: • Oversee luxury residential construction, ensuring high standards., • Ensure proper use of construction techniques and materials. Qualifications: • Bachelor’s degree in construction management, architecture, engineering, or a related field., • 5 to 10+ years of project management experience, ideally in luxury multi-unit, wood-frame residential construction, with the specific requirement depending on the level of the position., • Strong communication, negotiation, and team management skills., • Proficiency in using Procore, Microsoft Project, and other relevant construction technologies., • In-depth knowledge of value engineering and budget management., • Proficient in Procore and Microsoft Project Additional Requirements: • Strong knowledge of OSHA regulations and a commitment to safety. Work Environment: • A mix of office work and on-site project management., • Travel is required for project supervision and coordination. About The O'Neill Group: • The O'Neill Group is a leading firm in the real estate development sector, known for our innovative approach to land use, zoning, and planning. We pride ourselves on our collaborative culture, commitment to excellence, and our contributions to sustainable and community-focused development. Qualified candidates are encouraged to apply by submitting a resume, cover letter, and any relevant project portfolios

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