Clinical Trial Reg Affairs Specialist Ii - Tlahuac, México - Thermo Fisher Scientific
Descripción
Prepares and reviews regulatory submissions- Provides regulatory strategy as support RAL and RAL and/or technical advice to internal and external clients and acts as a liaison in executing strategies.
- Leads the development and implementation of projectspecific 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.
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