Hybrid Sr Reg Affairs Spec Sr Reg Affairs Spec with verification
Thermo Fisher Scientific · nan, · Hybrid
About the job
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.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.