Job Description

This prestigious CRO is looking for a Regulatory Affairs Associate I to be assigned to a project team to coordinate the regulatory & ethics submissions for ongoing studies.

Major Responsibilities include:
• Help define a regulatory strategy
• Reviewing & preparing regulatory documents for submissions
• Preparing, making, co-ordinating & tracking Regulatory & Ethics submissions
• Making other submissions
• Providing PM/Sponsor with status updates
• Arranging payments of Ethics Committees & Regulatory Authorities
• Ensuring compliance of regulatory approvals

General
• Provide support/advice on regulatory issues
• Arrange signing of appropriate contracts
• Assist in updating & maintaining in-house regulatory information
• Maintain regulatory project files

The successful candidate will:
• Establish effective relationships with all personnel
• Work on multiple tasks
• Have excellent attention to detail & written communication skills
• Be computer proficient

Qualifications/Skills Required

The successful candidate will have:
• Bachelor’s level degree in life sciences, pharmacy, nursing or RN, or equivalent clinical research experience
• Ability to learn and apply SOP’s and FDA regulations pertaining to clinical studies