Head of Regulatory Affairs

elemed; New York (NY); On-site; USD 260,000 - 360,000; Full time

Job summary

elemed seeks a Head of Regulatory Affairs to lead four oncology programmes, building a fully AI-enabled regulatory function. You will own IND lifecycle through registrational submissions and liaise with FDA and EMA, shaping strategy and documentation.

You will report to the CEO, hire a small team, and influence portfolio decisions with your regulatory perspective in a lean, AI-driven environment.

Qualifications

• 10+ years in regulatory affairs with senior leadership experience at VP level or equivalent.
• Led regulatory strategy for at least one oncology asset from Phase 1 to NDA/BLA with FDA interaction.
• Operated as sole senior regulatory leader in a lean organization, building teams and processes.
• RAC certification or an advanced scientific degree with EMA knowledge.

Responsibilities

• Own regulatory strategy across four oncology programmes, from IND to registrational submissions and post-marketing commitments.
• Lead health authority interactions directly, including pre-IND and advisory committee meetings with FDA/EMA.
• Design AI-native regulatory workflows and ensure AI-assisted submissions meet quality standards.
• Define how AI-informed evidence is presented in IND amendments and registrational submissions.
• Establish compliance framework for AI submissions, including SOPs and audit trails (GxP).
• Build and lead a small regulatory team (2–4 people) delivering with AI as the operating layer.
• Contribute to portfolio governance with regulatory judgment guiding go/no-go decisions.
• Coordinate CMC alignment across timelines and oversee CRO regulatory deliverables.

Skills

Regulatory leadership

Pharma/biotech

FDA interactions

IND/NDAs

AI in regulatory

CMC regulatory

GxP

Team building

Regulatory strategy

EMA familiarity

Education

RAC certification

Advanced degree (PharmD/PhD)

Tools

eCTD software

Job description

Title: Head of Regulatory Affairs

You've led an FDA approval. You know exactly where the inefficiency lives in traditional regulatory affairs. Now someone is asking you to rebuild the whole function around AI, from scratch, reporting to the CEO.

The Company

This is a clinical-stage oncology company that doesn't operate like a traditional biotech. It was built from first principles around an AI and technology core, with a model trained on multimodal oncology data spanning genomics, transcriptomics, imaging, and longitudinal clinical outcomes.

That model feeds a decision-making platform used in live portfolio governance.

The company has four clinical-stage oncology programmes and a co-development partnership with a top-five pharma. It is well-capitalised. Leadership brings nearly two decades of company-building experience and multiple successful exits. The team today numbers 40 to 50 people doing the work of a traditional biotech three times its size, and every function is built the same way: a small group of deep experts, each directing dozens of AI agents.

Regulatory affairs is one of the last functions in drug development that hasn't been fundamentally rethought. That's what this hire is for.

The Opportunity

Four clinical-stage oncology programmes need a Head of Regulatory Affairs who can own strategy across all of them, from IND lifecycle through registrational submission and approval. There has been no senior regulatory hire before you. You are building this function, and you are building it differently to how anyone has built it before.

AI is the default operating layer here, not a tool bolted onto legacy workflows. You will design and implement regulatory processes where submission assembly, eCTD compilation, regulatory intelligence monitoring, labelling review, and compliance tracking all run through AI agents, with your review and sign-off on every deliverable. The goal is to cut submission preparation timelines by 50% or more, and then prove it works.

You will also be working at the frontier of something genuinely new. When an AI-informed platform informs a trial design, a dosing decision, or a biomarker selection, you own the regulatory framing for how that evidence appears to the FDA, EMA, or any other health authority. The regulatory landscape for AI-driven drug development is still being written. You will be one of the people writing it.

You report directly to the CEO and sit as a peer to the rest of the executive team. Your regulatory judgement is a direct input into portfolio decisions, deal structures, and how the company engages with health authorities. You will hire a team of two to four people and set the standard for what a lean, AI-enabled regulatory function can deliver.

What You'll Be Doing

• Own regulatory strategy across a four-programme oncology portfolio, from IND lifecycle management through registrational submissions, labelling, and post-marketing commitments.
• Lead all health authority interactions directly, including pre-IND meetings, Type A/B/C meetings, end-of-Phase-II meetings, and advisory committee preparation with the FDA and EMA.
• Design and implement AI-native regulatory workflows from day one, deploying AI agents across submission assembly, regulatory intelligence monitoring, safety narratives, and briefing document preparation.
• Define how AI-informed evidence is presented to regulators, including the framing of platform-driven decisions in IND amendments, briefing books, and registrational submissions.
• Establish the compliance framework for AI-assisted submissions, including SOPs, quality standards, audit trails, and human review chains that satisfy GxP standards and emerging FDA and EMA AI/ML guidance.
• Build and lead a small team of regulatory operators, setting the bar for what two to four people can deliver when AI is the operating layer.
• Contribute to pipeline and portfolio governance as a strategic peer to the CEO and executive team, with regulatory judgement shaping go/no-go decisions at every stage gate.
• Manage CMC regulatory alignment across clinical and chemistry and manufacturing timelines, and oversee CRO regulatory deliverables where work is outsourced.

What We're Looking For

• 10 or more years in regulatory affairs in pharma or biotech, with senior leadership experience at VP level or above, or equivalent scope at a smaller organisation.
• Personally led regulatory strategy for at least one oncology asset from Phase 1 through NDA or BLA approval as the lead regulatory person, with direct FDA interaction experience across pre-IND, end-of-Phase-II, and pre-NDA/BLA meetings.
• Demonstrated ability to operate as the sole senior regulatory leader in a lean organisation, making high-judgement calls independently and building teams and processes without an existing structure to inherit.
• RAC certification or an advanced scientific degree (PharmD, PhD, or equivalent), with strong working knowledge of EMA scientific advice procedures and global regulatory requirements.