McKesson is hiring a Regulatory Affairs Manager to lead regulatory strategy and operations for Sarah Cannon Site Clinical Operations. In this mission-critical role, you will manage the Regulatory Department and ensure all activities comply with FDA regulations and Good Clinical Practice.
What You'll Do
- Manage, direct, plan, and schedule all activities and programs for the regulatory department.
- Establish and enforce procedures to ensure all trial teams and sites are fully compliant with applicable laws, regulations, SOPs, and guidelines.
- Develop and implement regulatory policies and procedures for the sites and the site Clinical Operations team.
- Manage and plan regulatory affairs compliance for industry sponsors and/or sites.
- Manage regulatory affairs for multiple clinical trials according to FDA and GCP guidelines.
- Manage relationships between industry partners and the FDA regarding regulatory compliance.
- Manage regulatory audits of studies by sponsor/industry and governmental auditors.
- Resolve key regulatory issues with Pharmaceutical Industry Partners and Government Agencies.
- Develop and implement an approved archiving system for study-specific regulatory documentation and correspondence.
- Apprise management of important regulatory issues and obtain guidance when necessary.
- Attend network meetings, conference calls, and monthly staff meetings as appropriate.
- Visit strategic sites to provide training and mentoring as needed.
- Provide proactive and creative recommendations on how to meet goals and handle identified deviations.
- Be responsible for objective setting, performance management, education, and training of the regulatory staff.
- Be responsible for implementing, managing, and refining departmental processes.
- Initiate improvements, tools, and forms to enhance the efficiency and quality of work performed on assigned projects.
What We're Looking For
- A Bachelor’s Degree
- Knowledge of scientific and clinical research terminology
- Knowledge of FDA and GCP guidelines
- Knowledge of organizational policies, procedures, and systems
- At least three years of experience in regulatory affairs
- At least one year of experience in a supervisory role
Team & Environment
You will manage the Regulatory Department, guiding its strategy and operations to support our clinical research mission.
Benefits & Compensation
- Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being
- Competitive compensation package determined by performance, experience, skills, equity, regular job market evaluations, and geographical markets
McKesson is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
