Reg Affairs Spec

**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...

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 member with regulatory affairs responsibilities, leading discussions, and...

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...

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...

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...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Essential Functions and Other Job Information**: - Provides administrative support to the department. - Assist with projects’ archiving of documents and submissions. - Provides project specific services, documentation and coordination of projects and supports reporting of same...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Essential Functions and Other Job Information**: Coordinates and manages client electronic submission deliverables supporting regulatory compliance. - Assists in preparing electronic document outputs that meet requirements for regulatory publishing to include documents that work...

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...

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...