Regulatory Affairs Manager - CMC & Labeling
United Therapeutics Corporation
August 15, 2026
Remote friendly (Raleigh-Durham-Chapel Hill Area)
United States
Corporate Functions
Responsibilities:
- Manage and lead regulatory CMC activities to meet timelines and department goals; delegate tasks as required.
- Manage updates to quality sections of regulatory filings (e.g., INDs, NDAs, BLAs) and review quality submission documents for consistency with related filings and regulatory requirements.
- Coordinate with manufacturing and quality groups, and contract/partner organizations on CMC regulatory issues; provide strategic CMC regulatory interpretation and guidance.
- Mentor junior regulatory personnel; oversee training, goal setting, performance evaluations/management, coaching/mentoring, career development, and support recruitment as needed.
- Lead labeling activities as necessary (editing, review, QC, regulatory consistency) and lead internal labeling team meetings.
- Independently resolve complex, unprecedented CMC issues using knowledge, data interpretation, analysis, and problem-solving.
- Assist in dossier preparation and provide timely worldwide partner updates for accuracy and consistency.
- Support other regulatory and compliance activities; implement new technologies, practices, methods, or applicable regulatory guidance.
- Perform other duties as assigned.
Minimum Requirements:
- Bachelor’s degree in a science discipline.
- 8+ years regulatory affairs CMC experience (with BS), or 6+ years (with MS), or 2+ years (with PhD/PharmD).
- Experience with eCTDs/electronic document management or specialized pharma software.
- Excellent organizational, multitasking, and communication skills; strong attention to detail.
- Strong technical knowledge; proficient with MS Office.
- Ability to work independently and as part of a team; prioritize effectively.
Preferred Qualifications:
- Master’s degree and/or PhD or PharmD.
- Experience with drug/biologics and device labeling; diverse drugs/biologics and device experience.
- Familiarity with Trackwise, MasterControl, LIMS, Adobe.
- Manage and lead regulatory CMC activities to meet timelines and department goals; delegate tasks as required.
- Manage updates to quality sections of regulatory filings (e.g., INDs, NDAs, BLAs) and review quality submission documents for consistency with related filings and regulatory requirements.
- Coordinate with manufacturing and quality groups, and contract/partner organizations on CMC regulatory issues; provide strategic CMC regulatory interpretation and guidance.
- Mentor junior regulatory personnel; oversee training, goal setting, performance evaluations/management, coaching/mentoring, career development, and support recruitment as needed.
- Lead labeling activities as necessary (editing, review, QC, regulatory consistency) and lead internal labeling team meetings.
- Independently resolve complex, unprecedented CMC issues using knowledge, data interpretation, analysis, and problem-solving.
- Assist in dossier preparation and provide timely worldwide partner updates for accuracy and consistency.
- Support other regulatory and compliance activities; implement new technologies, practices, methods, or applicable regulatory guidance.
- Perform other duties as assigned.
Minimum Requirements:
- Bachelor’s degree in a science discipline.
- 8+ years regulatory affairs CMC experience (with BS), or 6+ years (with MS), or 2+ years (with PhD/PharmD).
- Experience with eCTDs/electronic document management or specialized pharma software.
- Excellent organizational, multitasking, and communication skills; strong attention to detail.
- Strong technical knowledge; proficient with MS Office.
- Ability to work independently and as part of a team; prioritize effectively.
Preferred Qualifications:
- Master’s degree and/or PhD or PharmD.
- Experience with drug/biologics and device labeling; diverse drugs/biologics and device experience.
- Familiarity with Trackwise, MasterControl, LIMS, Adobe.