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Posted 26 days ago · Thermo Fisher Scientific · Bangalore, India

Regulatory Affairs Specialist

The role

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

* Supports the preparation of documentation and submissions under EUCTR guidance. * Coordinates and manages client deliverables supporting regulatory compliance. * Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. * Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. * Evaluates client needs in relationship to overall project timelines, quality and delivery. * Engages with other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed * Provides project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients. * Supports preparation of bids and proposals; generates, tracks and analyses data for proposal, revisions, contract modifications and bid defenses.

Education and Experience:

Bachelor's or Master’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 2+ years)

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Regulatory Affairs Specialist at Thermo Fisher Scientific | JobTether