Regulatory Affairs Specialist

Thermo Fisher Scientific · Bengaluru

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)