Manager, Regulatory Affairs

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Oversee, direct, plan, and schedule activities and programs for the regulatory department.

• Create and enforce procedures to ensure that trial teams and sites adhere to applicable laws, regulations, SOPs, and guidelines.

• Formulate and execute regulatory policies and procedures for sites and the site Clinical Operations team.

• Manage and organize regulatory affairs compliance for industry sponsors and/or sites.

• Handle regulatory affairs for multiple clinical trials in accordance with FDA and GCP guidelines.

• Foster relationships with industry partners and the FDA concerning regulatory compliance.

• Oversee regulatory audits of studies conducted by sponsors, industry, and governmental auditors.

• Collaborate closely with department directors, primary investigators, industry sponsors, and external entities.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's Degree.

• 1+ year of work experience; 5+ years preferred in a clinical research corporation and regulatory team.

• Education may be considered as a substitute for partial experience.

• Familiarity with scientific and clinical research terminology.

• Understanding of FDA and GCP guidelines.

• Knowledge of organizational policies, procedures, and systems.

• Proficient in MS Office products, including Excel, Word, and Outlook.

• Proven ability to meet strict deadlines.

• Experience in supervising team members.

• Must be located in the US.

• Relocation assistance and visa sponsorship are not available.

🏝️ Benefits

• Comprehensive Total Rewards package that promotes physical, mental, and financial well-being.

• Competitive compensation package.

• Opportunities for annual bonuses or long-term incentives may be provided.

• Benefits offered through parent company McKesson.