Thermo Fisher Scientific is hiring Sr Reg Affairs Spec

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 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.

A seasoned, experienced professional with a full understanding of area of

specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.