Specialist - Regulatory Operations - Submissions

4 weeks ago


Princeton, United States Novo Nordisk AS Full time

The Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory submissions. This individual will be responsible for supporting the preparation, delivery, archiving and tracking of Promotional r Operations, Regulatory, Specialist, Operation, Management, Support, Manufacturing



  • Princeton, United States GForce Life Sciences Full time

    Consultant, GPV Case Management Product Specialist, Pharmaceuticals Summary Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing. This candidate will collaborate with Regulatory...


  • Princeton, United States GForce Life Sciences Full time

    Consultant, GPV Case Management Product Specialist, Pharmaceuticals Summary Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing. This candidate will collaborate with Regulatory...


  • Princeton, United States GForce Life Sciences Full time

    Consultant, GPV Case Management Product Specialist, Pharmaceuticals Summary Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing. This candidate will collaborate with Regulatory...


  • Princeton, United States GForce Life Sciences Full time

    Consultant, GPV Case Management Product Specialist, Pharmaceuticals SummaryOur growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing. This candidate will collaborate with Regulatory...


  • Princeton, United States GForce Life Sciences Full time

    Consultant, GPV Case Management Product Specialist, Pharmaceuticals SummaryOur growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing. This candidate will collaborate with Regulatory...


  • Princeton, United States GForce Life Sciences Full time

    Consultant, GPV Case Management Product Specialist, Pharmaceuticals SummaryOur growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing. This candidate will collaborate with Regulatory...


  • Princeton, United States Navitas Life Sciences Full time

    We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will: Develop and execute novel drug regulatory strategy Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines Establish sound regulatory advice/position on key development issues,...


  • Princeton, United States Guerbet Full time

    Guerbet is a human-scale company that aims to become a new global leader in medical imaging. Pioneer in contrast media with 90 years' experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors. The company offers a comprehensive range of...


  • Princeton, United States GUERBET Full time

    Apply now " Date: Apr 30, 2024 Location: Princeton, NJ (USA), US Job Type: Graduate At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and...


  • Princeton, United States Guerbet Full time

    Apply now " Date: Apr 30, 2024 Location: Princeton, NJ (USA), US Job Type: Graduate At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional...


  • Princeton, United States GUERBET Full time

    Apply now " Date: Apr 30, 2024 Location: Princeton, NJ (USA), US Job Type: Graduate At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and...


  • Princeton, United States TK-CHAIN LLC Full time

    **SUMMARY OF POSITION** Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates,...


  • Princeton, United States eTeam Full time

    Job Title: Regulatory Affairs Manager Location: Princeton, NJ 08540 Duration: 6+ Months Duties: **Can be hybrid, but this role will be mostly onsite in Princeton, NJ. Local candidates.** Supports regulatory affairs projects to organize, analyze, identify, track and resolve submission and filing issues, and maintain compliance Suffixes...


  • Princeton, United States eTeam Full time

    Job Title: Regulatory Affairs Manager Location: Princeton, NJ 08540 Duration: 6+ Months Duties: **Can be hybrid, but this role will be mostly onsite in Princeton, NJ. Local candidates.** Supports regulatory affairs projects to organize, analyze, identify, track and resolve submission and filing issues, and maintain compliance Suffixes...


  • Princeton, United States TK-CHAIN LLC Full time

    **SUMMARY OF POSITION** The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions will include ANDAs, amendments, supplements, Annual Reports and advertising...


  • Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...


  • Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...


  • Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...


  • Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...


  • Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...