Regulatory Affairs Manager - Remote

Overview

As the Manager of Regulatory Affairs, you will oversee all aspects of regulatory operations for Sarah Cannon Site Clinical Operations, ensuring compliance with FDA regulations and managing the Regulatory Department.

In Short

• Oversee regulatory operations for clinical trials.
• Ensure compliance with FDA and GCP guidelines.
• Manage relationships with industry partners and regulatory agencies.
• Develop and implement regulatory policies and procedures.
• Conduct training and mentoring for regulatory staff.
• Resolve key regulatory issues with pharmaceutical partners.
• Implement an archiving system for regulatory documentation.
• Attend network meetings and provide updates on regulatory issues.
• Initiate improvements for efficiency and quality in regulatory processes.
• Responsible for performance management of the regulatory team.

Requirements

• Bachelor’s Degree.
• Knowledge of scientific and clinical research terminology.
• At least three years of experience in regulatory affairs.
• One year of supervisory experience.
• Understanding of organizational policies and procedures.
• Strong communication skills.
• Ability to work collaboratively with clinical teams.
• Proactive problem-solving abilities.
• Experience managing regulatory audits.
• Familiarity with drug development processes.

Benefits

• Comprehensive benefits package for physical, mental, and financial well-being.
• Competitive compensation determined by performance and experience.
• Opportunities for annual bonuses or long-term incentives.
• Support for professional development and training.
• Diverse and inclusive workplace culture.
• Access to healthcare and wellness programs.
• Flexible working arrangements.
• Employee assistance programs.
• Opportunities to make a difference in cancer care.
• Networking opportunities within the oncology research community.