Regulatory Affairs Specialist

Overview

Supports regulatory documentation and submissions under EUCTR guidance and coordinates client deliverables that support regulatory compliance.

What you'll do

• Support the preparation of documentation and submissions under EUCTR guidance.
• Coordinate and manage client deliverables supporting regulatory compliance.
• Liaise with internal and external clients on tracking and status updates of project plans and overall project support.
• Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
• Evaluate client needs in relation to overall project timelines, quality and delivery.
• Engage with project team members, functional units and/or management to deliver the final product and resolve or mitigate issues or barriers to delivery.
• Provide project-specific services, documentation and coordination, and support reporting to management, internal and external clients.
• Support preparation of bids and proposals; generate, track and analyse data for proposals, revisions, contract modifications and bid defenses.

What you'll need

• Bachelor's or Master's degree or equivalent, and relevant formal academic or vocational qualification.
• Previous experience providing the knowledge, skills and abilities to perform the job (comparable to 2+ years).

Details

• Work schedule: Standard, Monday to Friday.
• Environmental conditions: Office.
• Location: Bangalore, India.