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Job Information

ThermoFisher Scientific Sr Reg Affairs Spec in Remote, Mexico

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.

Qualifications:

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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