Reg Affairs Assistant

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office We are currently seeking a Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office In this role as a Sr Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects. You will be part of a global team providing innovative...

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

Summarized Purpose: Provides advanced administrative support to the department and supports reporting of such to upper management. Essential Functions - Track each regulatory submission in required tracker system (PPD or sponsor), (Veeva, eTMF, Activate, CTMS). - Review Sharepoint to ensure correct regulatory information is captured as per the tracked...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office This a client dedicated role for a Regulatory Affairs Specialist role. Job Purpose Works closely with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), global submission teams and Local Operating Company regulatory contacts to deliver submissions to agreed timelines...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - Prepares and reviews regulatory submissions. - Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies. - Leads the development and implementation of project-specific processes for sponsors. - Collaborates...

Supports the preparation of documentation and submissions under guidance - Coordinates and manages client deliverables supporting regulatory compliance - Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects - Assists with project budgeting/forecasting - Maintains knowledge and...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The following skills are required to be successful in this position: - preparation and assembly of global regulatory submissions - interacting with sponsors, - review and assess clinical trial regulatory documents, - review and assess scientific literature. - manages project teams...

Coordinates timely collection of data, metrics, experience statements for proposal and budget development in response to Request for Propoals (RFPs). - Supports bids and proposals; generates, tracks and analyzes data for proposal, revisions, contract modicifcations and bid defenses. - Supports department management in reporting financial, contractual and...

Act as an administrator for our in-house Regulatory Intelligence database and provide customer support for issues arising. - Regulatory collaboration with Regulatory Intelligence database workflow users to drive quarterly EQR metrics. - Contribute to a wide range of technical Regulatory Intelligence database content projects including engineering and...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Essential Functions and Other Job Information**: - Supports the preparation of documentation and submissions of North American IRB and REB submissions - Coordinates and manages client deliverables supporting regulatory compliance. - Liaises with internal and external clients in...

**Job Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. **Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...