Job Openings Clinical Trial Reg Affairs Specialist III

About the job Clinical Trial Reg Affairs Specialist III

Job Title: Clinical Trial Reg Affairs Specialist III

Job Location: India

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

  • 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 4+ years)



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