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Hybrid Sr Reg Affairs Spec Sr Reg Affairs Spec with verification

Thermo Fisher Scientific  ·  nan, · Hybrid

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About the job

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.

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.

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