Regulatory Affairs Specialist - Remote

Overview

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

In Short

• Manage clinical trial applications to various authorities.
• Research and report on global regulations.
• Develop stakeholder tools.
• Process and document regulatory risk assessments.
• Provide expertise and support to functional units.
• Ensure timely service delivery in line with standards.
• Coach peers and provide input for performance reviews.
• Maintain high-quality service delivery processes.
• Represent the unit with sponsors and regulatory authorities.
• Adhere to corporate and industry guidelines.

Requirements

• Experience in Global Regulatory Affairs.
• Knowledge of clinical trial processes.
• Strong understanding of regulatory requirements.
• Excellent communication skills.
• Ability to work collaboratively with various stakeholders.
• Experience in coaching and mentoring.
• Detail-oriented with strong organizational skills.
• Ability to manage multiple projects simultaneously.
• Proficient in regulatory documentation.
• Ability to analyze and interpret regulations.

Benefits

• Competitive salary.
• Health and wellness programs.
• Opportunities for professional development.
• Supportive work environment.
• Flexible working hours.
• Comprehensive benefits package.
• Collaborative team culture.
• Access to industry conferences.
• Potential for career advancement.
• Work-life balance initiatives.