Regulatory Affairs Manager - CMC & Labeling

Location: Durham, NC, United States; hybrid schedule with 4 days in the office and 1 day working from home. Travel may be required up to 10%. Relocation assistance may be available for non-local candidates.

Company

hirify.global is a publicly traded biotech and pharmaceutical company developing therapies for rare diseases and technologies for manufactured transplantable organs.

What you will do

• Manage and lead regulatory CMC activities for assigned products and territories, including task delegation and timeline delivery.
• Prepare, update, and review quality sections of IND, NDA, BLA, and related regulatory filings.
• Develop CMC regulatory strategies and provide interpretation and guidance to project teams, manufacturing, quality, partners, and contract organizations.
• Lead labeling activities, including editing, review, quality control, consistency checks, and internal labeling meetings.
• Prepare dossiers and provide accurate regulatory updates for worldwide partner organizations.
• Mentor junior regulatory personnel and support training, performance management, career development, and recruitment activities.

Requirements

• Bachelor’s degree in a science discipline.
• 8+ years of direct regulatory affairs CMC experience with a bachelor’s degree, 6+ years with a master’s degree, or 2+ years with a PhD or PharmD.
• Experience with electronic publishing tools such as eCTD systems, electronic document management systems, or comparable pharmaceutical software.
• Strong organizational, multitasking, communication, problem-solving, and attention-to-detail skills.
• Technical proficiency with Microsoft Office and the ability to prioritize multiple projects independently and collaboratively.
• Ability to work in the Durham, NC office 4 days per week under the hybrid schedule.

Nice to have

• Master’s degree, PhD, or PharmD in a science discipline.
• Experience with drug, biologic, and device labeling.
• Diverse experience across drugs and biologics, including device experience.
• Familiarity with Trackwise, MasterControl, LIMS, or Adobe.

Culture & Benefits

• Mission focused on addressing unmet medical needs and expanding access to transplantable organs.
• Eligible employees may receive medical, dental, vision, and prescription coverage.
• Benefits may include wellness resources, 401(k), ESPP, paid time off, paid parental leave, and disability coverage.
• Hybrid work arrangement with one scheduled work-from-home day per week.