Regulatory Affairs Manager, CMC — Global Submissions

United Therapeutics Corporation; United States; Hybrid; USD 120,000 - 190,000; Full time

Job summary

United Therapeutics Corporation in Durham, NC is seeking a Regulatory Affairs Manager (CMC) to lead submission planning for US, EU, and ROW. Hybrid work with 4 days in office and up to 1 day remote weekly, travel up to 10%, and relocation assistance for non-local candidates.

The role requires extensive CMC knowledge, collaboration with manufacturing and QA, and leadership of junior staff to ensure timely, compliant regulatory deliverables across multiple projects in a fast-paced biotech

Qualifications

• Bachelor’s degree in science required; advanced degrees preferred.
• 8+ years in regulatory affairs CMC with Bachelor’s, or 6+ with Master’s, or 2+ with PhD/PharmD.
• Experience with electronic publishing tools (eCTD) or related software.
• Strong organizational, multitasking and communication skills; attention to detail.

Responsibilities

• Manage and lead regulatory CMC activities to meet timelines and department goals for assigned products and territories, delegating tasks as required.
• Manage and lead updates to quality sections of regulatory filings (INDs, NDAs, BLAs, etc.) and review of quality submission documents for consistency with filings and regulatory requirements.
• Interact with manufacturing and quality groups, contract and partner organizations regarding CMC regulatory issues and provide strategic CMC regulatory interpretation and guidance to project teams.
• Mentor junior regulatory personnel; direct and manage training, goal setting, performance evaluations, and recruitment support as needed.
• Perform and lead labeling activities, including editing, review and QC, ensuring regulatory compliance and leading internal labeling team meetings.
• Work independently on assigned projects using knowledge, experience, data interpretation, analyses, and problem-solving to resolve complex CMC issues.
• Assist in dossier preparation and provide timely updates for partner organizations in worldwide territories.
• Contribute to other regulatory and compliance activities with project teams and other regulatory personnel.
• Implement new technologies, practices, methods, or regulatory agency guidance applicable to job function.
• Perform other duties as assigned.

Skills

Organizational skills

Multitasking

Communication skills

Team leadership

MS Office

Regulatory affairs knowledge

Education

Bachelor’s degree in science

Master’s degree in science (preferred)

PhD or PharmD (preferred)

Tools

eCTD publishing tools

TrackWise

MasterControl

LIMS

Adobe

Job description

United Therapeutics Corporation in Durham, NC is seeking a Regulatory Affairs Manager (CMC) to lead submission planning for US, EU, and ROW. Hybrid work with 4 days in office and up to 1 day remote weekly, travel up to 10%, and relocation assistance for non-local candidates.

The role requires extensive CMC knowledge, collaboration with manufacturing and QA, and leadership of junior staff to ensure timely, compliant regulatory deliverables across multiple projects in a fast-paced biotech