Thermo Fisher scintific Job opening for Reg Affairs Specialist – Apply Now

Work Schedule

Standard (Mon-Fri) 

Environmental Conditions

Office 

Job Description

 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 extensively with other departments, regulatory consultants, and
regulatory authorities.
 Assists in identifying and recognizing out of scope activities in a contract in a
timely manner and liaises with other departments to follow through on all
aspects of contract modifications.
 Provides training and guidance to junior team members as appropriate.
 Participates in project launch meetings, review meetings and project team
meetings.
 Supports business development activities, including project
budgeting/forecasting.

> Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors

Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.