---
title: 'Senior Director, Regulatory Affairs at ARTBIO'
canonical: 'https://feeny.ai/job/senior-director-regulatory-affairs-artbio-cambridge-0ns089vpm244'
type: 'job'
last_seen: '2026-10-20'
---

# Senior Director, Regulatory Affairs at ARTBIO

- **Company:** ARTBIO
- **Location:** Cambridge, MA
- **Employment:** full-time
- **Work type:** remote
- **Posted:** 2026-09-22
- **Last confirmed live:** 2026-10-20
- **Apply:** https://jobs.lever.co/artbio/ce060b5c-b7d0-4806-a335-497f12061754

## Job description

Summary The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution for ARTBIO’s clinical-stage radiopharmaceutical programs. This role is primarily responsible for coordinating regulatory medical writing across functions. The position works cross-functionally to translate research and development data and strategy into clear, compliant regulatory communications and high-quality submission deliverables.

## Key Responsibilities

- Serves as the point of contact for Health Authorities.
- Translates program regulatory strategy into clear interaction plans, submission plans, timelines, and cross-functional deliverables for ARTBIO’s clinical-stage radiopharmaceutical programs.
- Leads the preparation, coordination, and delivery of regulatory submissions, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle submissions.
- Schedules and coordinates meeting rehearsals prior to Health Authority interactions.
- Finalizes meeting minutes with Health Authorities, responses to information requests, and follow-up actions.
- Oversees publishing and submissions.
- Partners with Clinical, Medical, CMC, Quality, Nonclinical, Clinical Operations, and other contributors to develop content, resolve data gaps, and maintain an aligned submission narrative.
- Maintains clear records of correspondences, commitments, decisions, and submission history.
- Establishes and maintains regulatory plans, workflows, submission calendars, trackers, and archives.

## Qualifications & Education

- Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required; an advanced degree is preferred.
- 12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry, including demonstrating leadership in leading the deliverables for regulatory interactions supporting pre-IND to Phase 3 investigational-stage programs in oncology.
- Strong knowledge of US FDA requirements and interaction processes
- Proven track record coordinating US INDs, IND amendments, annual reports, health authority meeting packages, and responses to US FDA information requests.
- Hands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendors.
- Experience and familiarity with leading submission of New Drug Applications, Marketing Authorization Applications, and radiopharmaceutical development are helpful.

Personal Attributes

- Clear, concise communicator with strong scientific judgment and exceptional writing and editing skills.
- Highly organized, proactive, and detail-oriented, with disciplined follow-through on commitments and timelines.
- Comfortable working in a fast-paced biotech environment with evolving priorities and multiple stakeholders.
- Collaborative leader who can align subject matter experts, challenge constructively, and drive decisions without losing momentum.
- Commitment to quality, compliance, and patient safety.

## What We Offer

- A unique chance to contribute to first-in-class cancer therapies.
- Exposure to both radiochemistry and CMC development in a dynamic biotech setting.
- Hands-on training and professional development opportunities.
- An international, collaborative, and supportive work culture.
- Competitive compensation and benefits.

## About Us

Channeling Energy. Changing Lives. ARTBIO redefines cancer care by discovering and developing a new class of Alpha Radioligand Therapies (ARTs), powered by unique Pb-212 isotope technology and seamless supply. Our team works tirelessly to bring therapies that matter to patients who need them.

The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for the highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs, with lead program AB001 currently in first-in-human trials. The company is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital.

Cancer is relentless. So are we. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration. As an emerging, global biotech with locations in Boston, Basel, London, and Oslo, we take advantage of diverse scientific depth and insights, which makes ARTBIO a unique place to work.

## EEO Statement

ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Questions and Application Process If interested, please apply and send your CV to HR@artbio.com. All inquiries are treated confidentially.

ARTBIO does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to unsolicited resumes.

## About ARTBIO

## Company Overview
- **One-liner**: ARTBIO is a clinical-stage radiopharmaceutical biotechnology company developing a new class of alpha radioligand therapies (ARTs) for cancer, powered by its proprietary Pb212 isotope technology and integrated manufacturing ecosystem.
- **Entity Type**: Private (Series B)
- **Headquarters**: Cambridge, Massachusetts, USA
- **Founded**: 2021
- **Founders**: Roy Larsen, Øyvind Bruland (scientific founders, collaborating with F-Prime and Radforsk)

## Core Business
- **Primary industry**: Biotechnology, radiopharmaceuticals, oncology
- **Target customers**: B2B (healthcare providers, pharma partners) and B2C (patients; ultimately market access to cancer treatments)
- **Mission or purpose statement**: "Redefining cancer care by developing a new class of alpha radioligand therapies (ART) and building an ecosystem that maximizes their potential" ([artbio.com](https://artbio.com/))

## Products & Services
- **AB001 (212Pb-NG001)**: Lead program, a Pb212-labeled therapy for prostate cancer, currently entering first-in-human Phase 1 studies ([artbio.com](https://artbio.com/)).
- **Undisclosed pipeline programs (ABD, ABA, ABC)**: Fully-owned and in-licensed programs targeting indications including NSCLC, pancreas, and multiple solid tumors; targets remain undisclosed ([artbio.com](https://artbio.com/)).
- **AlphaDirect™**: Proprietary Pb212 isotope isolation technology designed to overcome supply chain limits of traditional alpha radioligand manufacturing ([artbio.com - Our Approach](https://artbio.com/our-approach/)).
- **Distributed ART manufacturing ecosystem**: A networked model for producing and delivering ARTs rapidly, in contrast to centralized beta-emitting RLT production ([artbio.com - Our Approach](https://artbio.com/our-approach/)).

## Market Standing
- **Valuation/Market Cap**: Not disclosed
- **Key Metric**: Total Funding — **$245M** (Seed $23M, Series A $90M, Series B $132M) ([linkedin.com](https://linkedin.com/company/artbio-inc))
- **Notable Investors/Partners**: Third Rock Ventures, Sofinnova Investments, B Capital, F-Prime, Radforsk ([linkedin.com](https://linkedin.com/company/artbio-inc))
- **Growth Signals**: Headcount of ~50 employees (+10.6% YoY); LinkedIn followers grew +35.4% year-over-year; operates across 5 countries (US, UK, Norway, Switzerland, Australia); lead program AB001 entered first-in-human studies ([linkedin.com](https://linkedin.com/company/artbio-inc), [artbio.com](https://artbio.com/))

## Competitive Advantages
- **Proprietary Pb212 isolation technology (AlphaDirect™)** provides a novel, scalable supply of an isotope with potentially better efficacy and safety than beta emitters ([artbio.com - Our Approach](https://artbio.com/our-approach/)).
- **Distributed manufacturing ecosystem** shortens time-to-patient and avoids the centralization bottlenecks common in radioligand therapy ([artbio.com - Our Approach](https://artbio.com/our-approach/)).
- **Scientific legacy**: Founded by the inventors of Xofigo (the first metabolically targeted alpha therapy, later acquired by Bayer), giving deep expertise in alpha particle therapy ([artbio.com](https://artbio.com/)).
- **Differentiated pipeline** with undisclosed targets in high unmet-need cancers, beyond the lead program ([artbio.com](https://artbio.com/)).

## Strategic Focus
- Advancing the lead program **AB001** through early clinical development.
- Expanding the pipeline through additional undisclosed targets and in-licensed assets.
- Building and scaling the **AlphaDirect™** isotope production and **distributed manufacturing** network to support a global portfolio.
- Growing the organization across Cambridge, Oslo, Basel, London, and Australia to attract specialized talent in radiopharmaceutical development ([artbio.com](https://artbio.com/), [linkedin.com](https://linkedin.com/company/artbio-inc)).

## Other roles at ARTBIO

- [Head of Regulatory Affairs](https://feeny.ai/job/head-of-regulatory-affairs-artbio-cambridge-02jswfn20sh0) — Cambridge, MA
- [Associate Director, CMC Development](https://feeny.ai/job/associate-director-cmc-development-artbio-oslo-6fdytmykabkv) — Oslo, Norway
- [Senior Director, Regulatory Affairs](https://feeny.ai/job/senior-director-regulatory-affairs-mirum-pharmaceuticals-foster-city-c00xsafh10k8) — Foster City, CA
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