Regulatory Affairs Manager - CMC & Labeling

Scorpion Therapeutics; Chapel Hill (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced Regulatory Affairs CMC Lead to drive filing strategies and ensure timely INDs/NDAs/BLAs. You will collaborate with Manufacturing, Quality, and external partners to align CMC content with regulatory expectations and company objectives.

Responsibilities include mentoring junior staff, overseeing labeling activities, managing eCTD submissions, and applying TrackWise/MasterControl practices.

Qualifications

• 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.

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.

Skills

CMC regulatory

Regulatory submissions

Team leadership

Communication skills

MS Office proficiency

Education

Bachelor’s degree in science

Master’s/PhD preferred

Tools

eCTD systems

TrackWise

MasterControl

LIMS

Adobe

Job description

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.