Works with personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs. The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interac...
The requirement is for 3 Regulatory Affairs Specialist. The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory submissions. Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to re...
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the pr...
Works with personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs. The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interac...
Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Represent RA on pro...
The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence contributes to the ongoing development, implementation, and successful execution of the scientific, operational, and regulatory reporting efforts in line with the overall WWPS needs. Pharmacovigilance (PV) Analytics and Rep...
Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities. Must make a proactive contribution to the overall Regulatory affairs departmen...
The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence contributes to the ongoing development, implementation, and successful execution of the scientific, operational, and regulatory reporting efforts in line with the overall WWPS needs. Pharmacovigilance (PV) Analytics and Rep...
Senior Director, Global Regulatory Affairs Strategy. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsibl...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
Summary:Program Manager is responsible to support & manage the day-to-day activities for new product launch projects with the objective to successfully commercialize and launch new products for SUN pharma. Area of Responsibility:Coordinate, Support & Align with Senior Program Leads on the Overall La...
Summary:Program Manager is responsible to support & manage the day-to-day activities for new product launch projects with the objective to successfully commercialize and launch new products for SUN pharma. Area of Responsibility:Coordinate, Support & Align with Senior Program Leads on the Overall La...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
Compliance and Regulatory Specialist Location: Somerset NJ Schedule M-F 8:30 to 5:00pm On site daily Duration: 3 month contract to hire Education: * Bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assuranc...
Regulatory Compliance Specialist (14450840). Senior Regulatory Compliance Specialist. Senior Regulatory Compliance Specialist. Supplier Quality, Regulatory Compliance, DEA, and QMS. ...
As a Compliance Specialist, you will be responsible to review new DBE applications and make recommendations regarding the applicant firm’s eligibility to participate in the DBE Program. Prepare a Certification Recommendation Report based on all information which has been reviewed and is an eva...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
Compliance and Regulatory Specialist. BCForward is hiring for highly motivated Senior Regulatory and Compliance Specialist in Somerset, NJ. Title: Senior Regulatory and Compliance Specialist. The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertai...
May supervise other project managers, technical professionals, and other design staff, including managing weekly project workload and manpower forecasting. This level may be achieved with ten years of experience in project production and technical professional activities, four of these working as a ...
Manages and leads project teams, vendors and stakeholders so that stated project objectives, benefits and solution requirements are met. Collaborates closely with other Line of Business (LOB) Project Managers and IT staff to leverage technology and resources across business areas. Conducts project m...
Site Start-Up & Regulatory Specialist II. Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SSUL. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or h...
Our 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 ...
Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...