Director Of Regulatory Affairs

Director of Regulatory Affairs

Location:RemoteHours:Full-time, with a minimum of 5 hours of daily overlap with U.S. Eastern Time (through approximately 2:00 PM ET)Employment Type:Full-timeReports to:U.S.-based Regulatory Lead

About the Company

We are a rapidly growing, U.S.-based clinical-stage biopharmaceutical company developing next-generation targeted radiotherapies for patients with difficult-to-treat and metastatic cancers. Our proprietary platform is designed to improve the therapeutic window of targeted radiopharmaceuticals — maximizing tumor control while reducing damage to healthy tissue.

Backed by recent institutional funding, we are advancing a lead asset in late-stage clinical development alongside an earlier-stage pipeline built on the same core technology. We operate as a lean, science-driven team of recognized experts, moving quickly and without the bureaucracy of large pharma.

About the Role

This role partners closely with our U.S.-based Regulatory Lead to drive regulatory execution across the portfolio. You will work independently to prepare briefing books, coordinate submissions, research and interpret agency guidance, and bring clear regulatory recommendations back to the development team.

You will not set strategy in isolation — our Regulatory Lead directs overall strategy — but you will be a major contributor: forming a well-reasoned point of view grounded in health authority guidance and helping the team decide the right path forward. Because we are a lean team, this is a hands-on role that rewards someone who can own a program with limited oversight and operate without significant hand-holding.

Key Responsibilities

Regulatory Execution & Program Support
* Independently prepare and coordinate briefing books and regulatory documents.
* Manage regulatory activities for a program or product, with oversight from the U.S.-based Regulatory Lead.
* Research, interpret, and apply health authority guidances, and provide clear regulatory recommendations to cross-functional teams.
Regulatory Strategy Contribution
* Contribute to program-level regulatory strategy, forming and communicating a point of view grounded in agency guidance.
* Identify regulatory risks and propose mitigations aligned with clinical, nonclinical, and CMC development plans.
Submissions & Lifecycle Management
* Coordinate regulatory submissions and amendments, including ongoing lifecycle activities such as annual reports.
* Ensure alignment across the clinical, nonclinical, and CMC components of submissions and support submission timelines.
Health Authority Engagement (Support)
* Support preparation for health authority interactions, including drafting regulatory questions, meeting objectives, and positioning.
* Document, interpret, and integrate health authority feedback into regulatory documents and development planning.
* Coordinate responses to health authority requests and manage related agency correspondence and follow-up.
Expedited & Designation Programs
* Author and support preparation of regulatory designation applications, such as Orphan Drug, Fast Track, and other applicable expedited programs.
Regulatory Intelligence
* Monitor evolving regulatory guidance relevant to the portfolio and advise the team on implications.

Required Qualifications
* Bachelor's degree in life sciences or a related discipline.
* Minimum 10 years of experience in biotechnology or pharmaceutical development, including direct Regulatory Affairs experience.
* Hands-on experience with FDA submissions, with the ability to operate independently and without significant hand-holding.
* Demonstrated ability to independently prepare briefing books, coordinate submissions, and manage regulatory projects with limited oversight.
* Excellent written and spoken English, with the ability to draft regulatory documents and agency responses fluently and coherently.
* Experience researching and applying health authority guidance to provide regulatory recommendations to teams.

Preferred Qualifications
* Radiopharmaceutical experience strongly preferred.
* If not radiopharmaceutical, small-molecule regulatory experience is preferred over biologics.
* Experience supporting (not necessarily leading) FDA or EMA agency interactions and briefing books.
* Familiarity with EMA processes and CTIS (the EMA clinical study portal) is a plus; a candidate fluent in FDA submissions can learn this on the job.
* Advanced degree (MS, PhD, PharmD) in a life sciences discipline.
* Background at a global CRO or multinational pharma with exposure to FDA and EMA filings for global sponsors.

Ideal Candidate Profile

You are:
* Independent and self-directed— you can own a program with light oversight and drive it forward.
* A strong writer and communicatorwho can produce clear regulatory documents and represent the work fluently in English.
* Scientifically fluent— comfortable engaging clinical, nonclinical, and CMC colleagues as a peer.
* Grounded in guidance— you b