Hybrid Regulatory Affairs Manager, CMC & Labeling

United Therapeutics Corporation; Durham (NC); Hybrid; USD 120,000 - 190,000; Full time

Job summary

United Therapeutics Corporation seeks a Regulatory Affairs Manager specializing in CMC and labeling. You will lead regulatory submissions across US, EU, and ROW, collaborate with manufacturing and QA, mentor junior staff, and drive labeling strategies.

Hybrid work model with Durham, NC location and up to 10% travel. The role requires extensive CMC regulatory experience, proficiency with eCTD and document management systems, and strong organizational skills.

Qualifications

• Bachelor’s Degree in a science discipline required.
• Extensive regulatory CMC experience (8+ years) or equivalent with advanced degree.
• Experience with eCTD publishing and electronic document management.
• Strong organizational, multitasking, and communication skills.
• Detail-oriented with ability to manage complex submissions.
• Proficient in MS Office and cross-functional teamwork.

Responsibilities

• Lead regulatory CMC activities to meet timelines and goals.
• Update quality sections of filings (INDs/NDAs/BLAs) for consistency.
• Interact with manufacturing, QA, and partners on regulatory issues.
• Mentor junior regulatory staff and support recruitment.
• Perform labeling activities and ensure regulatory compliance.
• Contribute to dossier preparation and worldwide regulatory updates.
• Implement new technologies and regulatory practices as applicable.
• Handle multiple projects with independent problem solving.

Skills

CMC knowledge

Regulatory submissions

Labeling

Leadership

eCTD publishing

Regulatory strategy

MS Office

Communication

Education

Bachelor’s degree in a science

Master’s degree preferred

PhD or PharmD

Tools

TrackWise

MasterControl

LIMS

Adobe

eCTD software

Job description

United Therapeutics Corporation seeks a Regulatory Affairs Manager specializing in CMC and labeling. You will lead regulatory submissions across US, EU, and ROW, collaborate with manufacturing and QA, mentor junior staff, and drive labeling strategies.

Hybrid work model with Durham, NC location and up to 10% travel. The role requires extensive CMC regulatory experience, proficiency with eCTD and document management systems, and strong organizational skills.