Regulatory Affairs Specialist - Remote

Overview

This role involves managing Global Regulatory Affairs support services, focusing on clinical trial applications and compliance with global regulations.

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 service delivery processes.
• Collaborate with sponsors and researchers.
• Represent the unit with regulatory authorities.

Requirements

• Experience in Regulatory Affairs.
• Knowledge of clinical trial processes.
• Strong communication skills.
• Ability to manage multiple stakeholders.
• Attention to detail and quality assurance.
• Experience in risk assessment.
• Ability to work in a team environment.
• Familiarity with corporate and industry standards.
• Coaching and mentoring skills.
• Problem-solving abilities.

Benefits

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