Regulatory Affairs Specialist - Remote

Overview

This role is responsible for managing Global Regulatory Affairs support services, ensuring compliance with regulations and delivering high-quality service.

In Short

• Manage clinical trial applications to regulatory authorities.
• Research and report on global regulations.
• Develop stakeholder tools and processes.
• Document regulatory risk assessments.
• Provide expertise and support to various units.
• Ensure timely service delivery in compliance with standards.
• Coach peers and provide input for performance reviews.
• Maintain high quality in service delivery processes.
• Represent the unit with sponsors and regulatory authorities.
• Collaborate with researchers and other functional units.

Requirements

• Experience in Regulatory Affairs.
• Knowledge of clinical trial processes.
• Strong communication skills.
• Ability to manage multiple stakeholders.
• Understanding of global regulatory standards.
• Experience in risk assessment.
• Coaching and mentoring skills.
• Attention to detail.
• Ability to work under pressure.
• Team player with a collaborative mindset.

Benefits

• Opportunity to work in a dynamic environment.
• Professional development opportunities.
• Collaborative team culture.
• Exposure to global regulatory processes.
• Potential for career advancement.