Are you a passionate IT trailblazer – a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working....
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 any additional duties or assignments as directed by Manager of 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 ...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
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...
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...
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 ...
This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. At least 8-10 years of relevant pharmaceut...
Performs quality control, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring that Good Clinical Practices (GCP) are adhered to and communicating protocol deviations appropriately per Standard Operating Procedures...
Regulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Ea...
The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compli...
Join us to be a part of an ever growing, elite IT team & start building your dream career today!To be a successful Regulatory Affairs Specialist you will embody GBSI's core employee characteristics of being passionate about IT, taking full ownership of your work & having a growth mindset. Represents...
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society. Compile, prepare, and review regulatory submission to US and EU. Anticipate regulatory obstacles and emerging issues throughout the product submission. Provide regulatory input for responsible countries/region fo...
As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. ...
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...
Hiring - Senior Regulatory Affairs Specialist. Assess applicable change requests for regulatory impact and follow-up on related regulatory action items. Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing US regulatory assessme...
Escalates program risks to the Program Director, or Program Sponsor, when appropriate. Supports planning, directing and coordination of day-to-day activities of running a program or portfolio of programs. This role will support the Enterprise Risk Technology team in ensuring that the program managem...
Senior Manager, Regulatory Affairs (BRANDED PRODUCTS). The Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), p. ...
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...
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...
Professional Land Surveyor - Survey Project Manager. Coordinate surveying tasks with project managers from multiple disciplines (civil engineering and landscape architecture). Project management for survey projects. Responsible for project schedules and completion of projects on deadline. ...
This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). More Years of direct regulatory affairs experience, including US labeling expe...