They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training. Reports to: Manager of Regulatory Affairs. Responsible for facility registrations, renewa...
Prepare new and maintain existing regulatory files in accordance with regional requirements, including but not limited to document updates, management of regulatory information in databases, and navigating document control systems. Review regulatory content for completeness, accuracy, consistency, a...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
The Regulatory Affairs Specialist will review and approve Dietary Supplement/Food labels for technical accuracy and compliance to all mandated regulatory requirements, provide information to rectify label issues and assist in resolving issues related to the use of customers’ label for packagin...
Eligibilities & qualifications....
Regulatory Affairs Specialist (Medical Device). Zing Recruiting, in partnership with an established medical equipment manufacturer stationed in Parsippany, New Jersey is on the search for an experienced Regulatory Affairs Specialist to join their team. Regulatory Affairs Specialist Responsibilities....
Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training. Responsible for facility registrations, renewals, and document submissions to regulatory ...
The Regulatory Affairs Specialist will review and approve Dietary Supplement/Food labels for technical accuracy and compliance to all mandated regulatory requirements, provide information to rectify label issues and assist in resolving issues related to the use of customers’ label for packaging. The...
Our client in Secaucus, NJ is looking to hire a Trade Compliance Analyst. The Trade Compliance Analyst is responsible for supply chain data analysis, with a focus on tariffs and freight costs. Assist in implementing corrective actions resulting from internal audits and compliance issues. Experience ...
Our client is looking to fill the role of CMC Regulatory Affairs. Minimum 5 years of Regulatory Affairs experience in the industry. Provide regulatory assessments of CMC change controls. Regulatory support for state and FDA inspections. ...
Product Stewardship Specialist. Product Regulatory expert for Construction Chemical Company responsible for preparing and releasing product safety information for finished and intermediates products across all technologies. Product Stewards operate SAP/Product Compliance and its Safety Data Sheet Ge...
The Regulatory Affairs Manager will be responsible for ensuring compliance with all regulatory standards and guidelines, leading the preparation and submission of regulatory documents including CMC modules, and overseeing the development of generics including Risk Evaluation and Mitigation Strategie...
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. Publish, review, submission and arc...
Are you a dedicated professional with a passion for quality and compliance in the medical biotech space? We are seeking a Quality Compliance Associate to join a leading company in medical biotechnologies. Supervise internal audits and manage quality functions across departments to uphold high compli...
Liaise with relevant project stakeholders within the Compliance business function and other technology teams. ...
Our client, a growing pharmaceutical company, has engaged GForce to provide a CMC Regulatory Affairs Manager Consultant. The role will be focused on providing CMC regulatory strategy input and expertise around investigational, new, and marketed biologic and small molecule drug products to assigned p...
The Program Manager (PM) will be responsible for planning and executing logistics for professional education speaker programs and activities. Database all program information and provide regular reports to the client on program status, program evaluations, financial status, and HCP-spend tracking. A...
The IT Project Manager will also define the project's objectives and oversee quality control throughout its life cycle. Job Summary: We are seeking a highly skilled IT Project Manager to join our dynamic team. Implement and manage project changes and interventions to achieve project outputs. The ide...
The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). E...
Escalates program risks to the Program Director, or Program Sponsor, when appropriate. Global Financial Firm located in Rutherford, NJ has an immediate contract opportunity for an experienced Program Manager. Supports planning, directing and coordination of day-to-day activities of running a program...
The Compliance Specialist assures on-going compliance and implements an effective compliance program under the direction of the Regional Compliance Officer. I The Compliance Specialist may assist the Regional Compliance Officer(s) with other aspects/projects/tasks/reviews of the Compliance Program t...
Edenbridge Pharmaceuticals is seeking a Senior Manager/Associate Director of Regulatory Affairs to join the Company at its Parsippany, NJ corporate office. Lead and manage a team of Regulatory Affairs professionals. Actively monitor changes in applicable regulatory requirements and industry trends, ...