Regulatory Affairs Manager - CMC & Labeling

About Us

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to develop treatments for rare, deadly diseases. Founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH), we now have six FDA-approved therapies treating PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma, a rare pediatric cancer. Our near-term pipeline focuses on additional therapies for PAH and pulmonary fibrosis (PF). We are also working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant, aiming to eliminate the transplant waiting list and cure end-stage organ diseases.

About the Role

The Regulatory Affairs Manager will manage and lead the preparation, compilation, and review of regulatory submissions and related CMC and labeling documents for US, EU, and rest-of-world (ROW) markets for assigned projects. This role collaborates with managers, project teams, and functional area representatives to devise and implement sound regulatory CMC and labeling strategies.

Responsibilities

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

Requirements

• Bachelor’s Degree in a science discipline.
• 8+ years of direct experience in 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), electronic document management systems, or other specialized software used within the pharmaceutical industry.
• Excellent organizational, multitasking, and communication skills.
• Strong attention to detail and project completion.
• Strong technical knowledge and proficiency in the use of MS Office suite.
• Experience and comfort working independently and as part of a team on multiple projects with the ability to prioritize effectively.

Preferred Qualifications

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

Schedule

This position is located at our Durham, NC office with a hybrid schedule of 4 days in-office and the option to work 1 day each week from home. In-office requirements may change based on business needs. This position may require up to 10% travel. Relocation assistance may be available for non-local candidates.

Benefits

Eligible employees may participate in the Company’s comprehensive benefits suite, including:

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

For additional information, visit United Therapeutics Benefits and Amenities.