Regulatory Affairs Manager, CMC & Labeling (Relocation assistance available)

United Therapeutics Corporation • NC

104d

About The Position

United Therapeutics seeks a Regulatory Affairs Manager to manage and lead the preparation, compilation, and review of regulatory submissions and related CMC and labeling documents pertaining to US, EU, and ROW for assigned projects. This role will collaborate with the manager, project teams, and functional area representatives to devise and implement sound regulatory CMC and labeling strategies. The manager will oversee regulatory CMC activities to meet established timelines and department goals for assigned products and territories, delegating tasks as required. Responsibilities include managing updates to quality sections of regulatory filings, interacting with manufacturing and quality groups, mentoring junior regulatory personnel, and leading labeling activities. The position requires independent work on assigned projects, contributing to regulatory and compliance activities, and implementing new technologies and practices as needed.

Requirements

• Bachelor’s degree in a scientific discipline.
• 8+ years of direct experience with a regulatory affairs CMC role with a bachelor's degree, or 6+ years with a master's degree, or 2+ years with a PhD or PharmD.
• Experience with electronic publishing tools (eCTDs) and electronic document management systems.
• Excellent organizational, multitasking, and communication skills.
• Strong attention to detail and project completion.
• Strong technical knowledge and proficient in MS Office suite.
• Experience working independently and as part of a team on multiple projects.

Nice To Haves

• Master’s degree in a scientific discipline.
• Doctor of Philosophy (PhD) or PharmD in a science discipline.
• Experience with drug, biologics, and device labeling.
• Diverse experience including drugs and biologics.
• Familiarity with operational systems (e.g., Trackwise, MasterControl, LIMS, Adobe).

Responsibilities

• Manage and lead the preparation, compilation, and review of regulatory submissions and related CMC and labeling documents.
• Collaborate with project teams and functional area representatives to devise and implement regulatory CMC and labeling strategies.
• Manage and lead regulatory CMC activities to meet established timelines and department goals.
• Oversee updates to quality sections of regulatory filings and review quality submission documents.
• Interact with manufacturing and quality groups regarding CMC regulatory issues.
• Mentor junior level regulatory personnel and manage direct reports.
• Perform and lead labeling activities, including editing and review of content.
• Assist in dossier preparation and provide updates for partner organizations.
• Contribute to other regulatory and compliance activities as required.
• Implement new technologies and practices for job function applicability.

Benefits

• Medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans (401k and ESPP).
• Paid time off & paid parental leave benefits.
• Disability benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees