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 ...
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...
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...
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...
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 –...
Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for ...
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. Responsible for facility registrations, renewals, and document submissions to regulatory ...
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...
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...
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...
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. ...
Senior Manager, Regulatory Affairs (BRANDED PRODUCTS). The Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), p. ...
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 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...
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...
Are you ready to impact how cutting-edge, non-opioid pain management solutions reach the world? My client is seeking a Senior Director of Regulatory Affairs Advertising & Promotion who will play a pivotal role in shaping the future of external product communications. In this key leadership posit...
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...