Manager, Regulatory Affairs

McKesson

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

Posted 11/6/2026full-timeRemote • Tennessee • United StatesJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regulatory affairs for clinical trials, ensuring compliance with FDA and GCP guidelines, and developing regulatory policies. Proven ability to lead teams, manage relationships with industry partners, and enforce compliance procedures.

Highest-signal resume keywords

Regulatory Affairs ManagementFDA Guidelines KnowledgeGCP Guidelines KnowledgeClinical Research ExperienceTeam Supervision

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceClinical Trial ManagementPolicy DevelopmentAudit ManagementScientific Terminology Knowledge

Soft Skills

Relationship ManagementDeadline Management

Tools & Technologies

MS OfficeExcelWordOutlook

Industry Keywords

Clinical ResearchRegulatory DepartmentSOPsTrial TeamsIndustry Sponsors

About the role

Key responsibilities & impact

Manage, direct, plan, and schedule activities and programs for the regulatory department
Establish and enforce procedures ensuring trial teams and sites comply with applicable laws, regulations, SOPs, and guidelines
Develop and implement regulatory policies and procedures for 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 with industry partners and the FDA regarding regulatory compliance
Manage regulatory audits of studies by sponsors, industry, and governmental auditors
Work closely with department directors, primary investigators, industry sponsors, and external entities
Perform other duties as assigned

Requirements

What you’ll need

Bachelor's Degree
1+ year work experience; 5+ years preferred in a clinical research corporation and regulatory team
Education may be substituted for partial experience
Knowledge of scientific and clinical research terminology
Knowledge of FDA and GCP guidelines
Knowledge of organizational policies, procedures, and systems
Advanced skills with MS Office products including Excel, Word, and Outlook
Experience meeting strict deadlines
Experience supervising team members
Must be based in the US
Relocation assistance and visa sponsorship are not available

Benefits

Comp & perks

Comprehensive Total Rewards package supporting physical, mental, and financial well-being
Competitive compensation package
Annual bonus or long-term incentive opportunities may be offered
Benefits through parent company McKesson