Regulatory Affairs Specialist

hace 1 día


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

We are seeking a highly skilled Regulatory Consultant to provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.

The ideal candidate will have strong understanding of FDA regulations and aseptic processing guidelines.

  • Provide expert regulatory advice for aseptic manufacturing processes, ensuring compliance with FDA and global regulatory standards.
  • Prepare and review regulatory submissions to the FDA, ensuring timely and accurate submission of required documents.
  • Assess and advise on the regulatory aspects of facility design, including clean room and aseptic manufacturing areas, to ensure compliance with FDA guidelines.

The selected candidate will be responsible for staying up-to-date with FDA regulations and industry standards for aseptic processing and pharmaceutical products. They will also support the preparation and submission of Corrective and Preventive Action (CAPA) plans and responses to regulatory authorities.



  • San Juan, San Juan, Puerto Rico Buscojobs Puerto Rico A tiempo completo

    About the Role:We are seeking a skilled Compliance Specialist to join our team at Buscojobs Puerto Rico. This is an excellent opportunity for individuals passionate about regulatory affairs and compliance.Job Description:The successful candidate will be responsible for monitoring and ensuring compliance with corporate policies, internal guidelines, and...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    Join Our TeamWe are a collaborative and innovative organization dedicated to delivering high-quality solutions to our clients. As a Regulatory Consultant with Qrc Group, Llc, you will have the opportunity to work with a talented team of experts who are passionate about regulatory affairs.Your Key ResponsibilitiesProvide expert regulatory advice for aseptic...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    Job OverviewThe Qrc Group, Llc is seeking a highly skilled Regulatory Consultant to join our team. As a key member of our regulatory affairs department, you will provide expert guidance and support in navigating the complex regulatory landscape.About the RoleIn this critical role, you will be responsible for providing expert regulatory advice for aseptic...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    Job DescriptionWe are seeking a highly skilled Regulatory Validation Specialist to join our team at Qrc Group Llc.The successful candidate will be responsible for leading projects focused on technology transfer, process optimization, and scale-up activities to support manufacturing operations.Oversee activities related to process validation, troubleshooting,...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    As a Regulatory Consultant at Qrc Group Llc, you will play a crucial role in ensuring the company's compliance with FDA regulations and guidelines. Your expertise in aseptic manufacturing and FDA product submissions will be invaluable to our team.Your key responsibilities will include providing expert regulatory advice for aseptic manufacturing processes,...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    We are looking for a highly motivated and experienced Regulatory Consultant to join our team at Qrc Group Llc. As a Regulatory Consultant, you will be responsible for providing expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.Your expertise in FDA regulations and aseptic processing guidelines...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    About UsQrc Group Llc is a dynamic organization committed to delivering high-quality solutions. We are seeking a talented Pharmaceutical Project Management Specialist to join our team. As a specialist, you will be responsible for overseeing projects focused on the implementation of digital and AI solutions that drive process performance and enhance...


  • San Juan, San Juan, Puerto Rico Upturn Co. A tiempo completo

    Job Description: Facility Management SpecialistThis role involves overseeing the day-to-day operations of a facility, ensuring it runs smoothly and efficiently.Main Objectives:To provide a safe and healthy environment for occupants, visitors, and employees.To maintain a clean and well-maintained facility that meets regulatory requirements.To ensure...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    About Our TeamWe are a dynamic and innovative organization dedicated to delivering high-quality solutions to our clients. Our team of experts works collaboratively to provide comprehensive support and guidance to our clients.What We OfferWe offer a competitive compensation package, including salary, benefits, and opportunities for professional growth and...

  • Validation Specialist

    hace 2 días


    San Juan, San Juan, Puerto Rico Psc Biotech A tiempo completo

    Psc Biotech OverviewAt Psc Biotech, we provide essential services to ensure health care products are developed, manufactured, and distributed to the highest standards. Our goal is to skyrocket our clients' success by employing a global team of skilled professionals and experts who span across strategically located offices in North America, Europe, Asia, and...


  • San Juan, San Juan, Puerto Rico Dcmc Partners A tiempo completo

    Job DescriptionWe are looking for a highly skilled Controls Engineer to provide oversight during design review and installation implementation for construction projects. The successful candidate will ensure all automation and control systems are optimized for performance, comply with regulatory standards, and support the safe and efficient operation of the...


  • San Juan, San Juan, Puerto Rico Sos Trabajo A tiempo completo

    OverviewWe are seeking a highly knowledgeable expert in access management, governance, and compliance to join our team at Sos Trabajo. As a key member of our organization, you will be responsible for supporting and improving our Identity and Access Management enterprise processes and applications.**Key Responsibilities:Assist in all Cybersecurity audits,...


  • San Juan, San Juan, Puerto Rico Dcmc Partners A tiempo completo

    Job Summary:We are seeking an experienced Program Coordinator to oversee the execution of multiple-related construction projects. This role will ensure project execution aligns with contract requirements, safety standards, and quality expectations while delivering on schedule.Main Responsibilities:Oversight & Execution: Provide strategic oversight for all...


  • San Juan, San Juan, Puerto Rico El Comeback A tiempo completo

    El Comeback Seeks Senior Commercial Lending SpecialistWe are a leading financial institution seeking a seasoned professional to fill the role of Senior Commercial Lending Specialist. This key position is responsible for evaluating commercial credit requests, renewals, and modifications, ensuring compliance with credit policies, risk management, and analysis...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    Key ResponsibilitiesAs a Validation Operations Manager, you will be responsible for:Developing and implementing process validation strategies to ensure compliance with regulatory requirements.Overseeing the introduction of new products or processes, including development of detailed project plans, timelines, and budgets.Ensuring effective communication and...


  • San Juan, San Juan, Puerto Rico El Comeback A tiempo completo

    Lead Commercial Credit Analyst at El ComebackThis critical role involves evaluating commercial credit applications, managing risk, and maintaining effective relationships with clients and internal stakeholders.Key Accountabilities:Gather and review financial information from various sources, guaranteeing accuracy and completeness.Assess commercial...


  • San Juan, San Juan, Puerto Rico Share Tech Group A tiempo completo

    We are currently seeking an exceptional Architect in Training to join our team at Share Tech Group. As an Architect in Training, you will be part of a dynamic team that values collaboration, innovation, and excellence in architectural design.Responsibilities and RequirementsThe successful candidate will have a Bachelor's degree in Architecture and a minimum...


  • San Juan, San Juan, Puerto Rico Enk A tiempo completo

    Job Overview:At Enk, we strive to create a safe working environment that prioritizes employee well-being. As a Project Health, Safety specialist, you will play a crucial role in achieving this goal.Responsibilities:Develop and implement an effective HSE strategy that aligns with regulatory requirements.Conduct regular health and safety audits to identify...


  • San Juan, San Juan, Puerto Rico Dcmc Partners A tiempo completo

    Job Title: Project CoordinatorCompany: Dcmc PartnersLocation: Various locations in Puerto RicoJob Type: Full-Time, Project-specificAbout Us: Dcmc Partners is a Great Place to Work Certified company specializing in disaster recovery, hazard mitigation, and crisis management with over 30 years of expertise.Job Summary:We are seeking an experienced Project...


  • San Juan, San Juan, Puerto Rico Infomedika A tiempo completo

    Our Mission\At Infomedika, we strive to provide exceptional customer service, deliver high-quality products, and foster a culture of innovation and excellence.\Job Summary\We are looking for a skilled Support Developer to join our team, responsible for resolving technical issues, improving software quality, and enhancing user experience.\Key...