VP, Regulatory Affairs

Job not on LinkedIn

October 3

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

⏰ Full Time

🔴 Lead

🚔 Compliance

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Implaion Recruiting

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Recruitment • Energy • Construction

Implaion Recruiting is a recruitment agency that prioritizes the human touch in the hiring process. Founded with the belief that great connections are built on understanding and trust rather than just data, Implaion aims to reimagine recruitment by fostering meaningful relationships between talent and opportunity. They specialize in various sectors, including Energy, Construction, and Life Sciences, emphasizing a people-first approach.

0 - 1 employees

🎯 Recruiter

⚡ Energy

📋 Description

• Take charge of planning, drafting, and submitting global regulatory filings including INDs, NDAs, CTAs, MAAs, and pediatric development plansowning everything from original submissions to post-approval documentation. • Lead cross-functional teams spanning nonclinical, clinical, CMC, stats, and operations, pushing programs forward while meeting tight timelines and quality expectations. • Drive strategic and hands-on regulatory operations throughout the product lifecyclefrom first-in-human to commercialization. • Partner with clinical and safety teams to manage labeling, risk mitigation strategies, pharmacovigilance requirements, and lifecycle management. • Interface directly with regulatory bodies (FDA, EMA, and others) and confidently lead agency meetings, teleconferences, and written communications. • Evaluate and implement fast-track mechanisms, adaptive design approaches, and other accelerated regulatory pathways to compress development timelines. • Ensure internal teams and external partners are aligned and equipped to meet regulatory milestones on time. • Oversee external regulatory writers and consultants, balancing internal ownership with outsourced support. • Maintain sharp awareness of global regulatory shiftsincluding FDA, EMA, and evolving EU regulationsand translate that into forward-looking action.

🎯 Requirements

• PharmD, PhD, or MD strongly preferred. • Minimum 10 years in Regulatory Affairs within biopharma, including substantial late-stage and global submission experience. • Hands-on leadership in at least two successful NDA submissions for novel therapeutics (rare disease background a plus), with meaningful post-approval involvement. • Proven track record preparing for and navigating regulatory inspectionscalm under pressure, thorough in execution. • Must have worked in a nimble, small-company setting and be energized by wearing multiple hats in a high-accountability, low-bureaucracy culture. • Strong command of international regulatory frameworks, including EU Clinical Trial Regulation and CTIS. • Comfortable leading Advisory Committee strategies and commercial label expansion efforts. • Fluent in GxP, FDA/ICH guidance, and global PV standards. • Experience with small molecule programs, ideally in immunology or autoimmune indications. • Skilled at toggling between high-level strategy and detail-driven executionyou dont shy away from writing submissions yourself. • Clear communicator, quick thinker, strong collaborator, and decisive leader.

🏖️ Benefits

• Remote work options