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....
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...
Our Senior Regulatory Affairs Specialist position is primarily focused on maintaining continued market access of our existing product portfolio, in addition to opportunities to provide regulatory support for new product development projects. The Senior Regulatory Affairs Specialist will work in BD S...
Our Senior Regulatory Affairs Specialist position is primarily focused on maintaining continued market access of our existing product portfolio, in addition to opportunities to provide regulatory support for new product development projects. Job Overview:The Senior Regulatory Affairs Specialist will...
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...
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...
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. ...
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...
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 ...
Our Senior Regulatory Affairs Specialist position is primarily focused on maintaining continued market access of our existing product portfolio, in addition to opportunities to provide regulatory support for new product development projects. The Senior Regulatory Affairs Specialist will work in BD –...
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...
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...
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...
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...
Eligibilities & qualifications....
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...
Senior Manager, Regulatory Affairs (BRANDED PRODUCTS). The Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), p. ...
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
Perform other regulatory tasks as assigned. Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies. ...
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...
The Regulatory Affairs Manager will be responsible for independently compiling and maintaining compliant US drug product applications throughout product lifecycle i. The Regulatory Affairs Manager is a self-motivated, detail-oriented, flexible team player who is able to multi-task, and work independ...
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...
The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for as...