Regulatory Project Coordinator

2 days ago


Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time
Job Overview

We are seeking a highly organized and proactive Regulatory Project Coordinator to support project management for marketing applications. This role will focus on timeline management, coordinating meetings, and maintaining communications in a dynamic environment.

Key Responsibilities
  • Implement industry-leading practices for managing diverse tasks and workflows in fast-paced settings.
  • Oversee system-based timelines, ensuring updates, adjustments, and critical issue reporting are handled promptly and efficiently.
  • Facilitate team collaboration by organizing essential documents and communications through platforms like SharePoint, OneNote, and OneDrive.
Requirements
  • BS degree with an emphasis on strong project management capabilities.
  • Must possess exceptional team-building and communication skills for effective leadership.
  • Highly organized and proactive, with the ability to multitask effectively and solve problems swiftly.
About Stratacuity

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.


  • Project Coordinator

    3 weeks ago


    Cambridge, Massachusetts, United States Massachusetts General Hospital Full time

    Job Summary:The Massachusetts General Hospital is seeking a highly motivated and organized Project Manager to join the Ragon Institute team. As a key member of the team, the successful candidate will be responsible for overseeing ongoing and new studies in South Africa related to women's health, HIV risk, pregnancy outcomes, the vaginal microbiome, and...


  • Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    Job Title: Associate Director, Regulatory OperationsAkebia Therapeutics is seeking an experienced Associate Director, Regulatory Operations to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing all regulatory operations activities, including project submission management, Smartsheet or MS project...


  • Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    About the RoleModerna Therapeutics is seeking a highly skilled Regulatory Strategy Manager to join our team in Cambridge, Massachusetts. As a key member of our Clinical Development team, you will play a critical role in developing and implementing regulatory strategies for our mRNA therapeutics.Key ResponsibilitiesDevelop and contribute to content, format,...


  • Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    Regulatory Operations DirectorAkebia Therapeutics is seeking a highly skilled Regulatory Operations Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the accuracy and timeliness of regulatory documentation, as well as providing guidance to the department to meet its application filing...


  • Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    {"title": "Regulatory Affairs Director", "content": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will be responsible for establishing and communicating regulatory strategies for development programs and coordinating the timelines, generation, and...


  • Cambridge, Massachusetts, United States Sarepta Therapeutics Full time

    Job SummarySarepta Therapeutics is seeking a highly experienced Regulatory Strategy Director to lead our regulatory affairs efforts. As a key member of our team, you will be responsible for developing and implementing regulatory strategies that ensure compliance with global regulations and facilitate the approval of our therapeutic programs.Key...


  • Cambridge, Massachusetts, United States Relay Therapeutics Full time

    The OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.This position requires weekly onsite presence and involves...


  • Cambridge, Massachusetts, United States The Steely Group Full time

    The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory leader who will guide drug development initiatives by leveraging extensive expertise to inform project teams on regulatory standards,...


  • Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    **This position requires 3 days onsite in Cambridge**The role acts as a liaison with Health Authorities and serves as the Regulatory Project Leader for various initiatives at different stages of development. Responsibilities include:Strategic LeadershipProvides expert regulatory guidance for assigned drug development projects, leveraging extensive knowledge...


  • Cambridge, Massachusetts, United States The Steely Group Full time

    The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and as a leader in regulatory projects across various development phases. This position is essential for guiding drug development initiatives and leveraging extensive regulatory knowledge to support project teams in navigating complex...


  • Cambridge, Massachusetts, United States The Steely Group Full time

    The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory leader who can effectively guide drug development initiatives by leveraging extensive expertise in regulatory frameworks.Key...


  • Cambridge, Massachusetts, United States The Steely Group Full time

    The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and as a leader for various regulatory projects at different stages of development. This position requires a strategic mindset to guide drug development initiatives and ensure adherence to regulatory standards.Key Responsibilities:Oversees the...


  • Cambridge, Massachusetts, United States The Steely Group Full time

    The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory expert who will guide drug development initiatives, leveraging extensive expertise to inform project teams on compliance requirements and...


  • Cambridge, Massachusetts, United States Relay Therapeutics Full time

    The OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.Your RoleDevelop and execute CMC global submission plans and...


  • Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time

    Job Title: Regulatory Affairs SpecialistBeam Therapeutics Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring the success of our global regulatory submissions.Key Responsibilities:Prepare and compile documentation packages for global regulatory...


  • Cambridge, Massachusetts, United States Harvard University Full time

    Job SummaryThe Senior Manager for Intergovernmental Policy and Regulatory Affairs at Harvard University plays a critical role in managing the University's interactions with state and local agencies and regulatory bodies. This position is responsible for coordinating and advancing the University's priorities through effective regulatory processes and policy...


  • Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job OverviewWe are seeking a highly skilled Regulatory Contracts Coordinator/Specialist to join our team at Stratacuity: Proven Scientific Placement. This role will be responsible for overseeing the regulatory contract process, from negotiating agreements and vendor setup to ensuring compliance and handling all related documentation.Key...


  • Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time

    Company Overview:Beam Therapeutics Inc. is a pioneering biotech company dedicated to developing innovative genetic medicines. Our mission is to establish a leading platform for precision genetic therapies, leveraging cutting-edge gene editing technologies to address serious diseases.Position Overview:The Regulatory Specialist will play a crucial role in...


  • Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time

    Company OverviewBeam Therapeutics Inc. is a pioneering biotech company dedicated to revolutionizing the field of precision genetic medicines. Our mission is to establish a leading platform for gene editing and delivery technologies, enabling the development of innovative treatments for serious diseases.We have assembled a cutting-edge platform that includes...


  • Cambridge, Massachusetts, United States Sarepta Therapeutics Full time

    About the RoleSarepta Therapeutics is seeking a highly skilled Regulatory Strategy Director to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on regulatory matters and ensuring compliance with global regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory...