Global Regulatory Head

Actithera

Global Regulatory Head directing Actithera’s radiopharmaceutical RLT regulatory strategy and submissions. Leading health authority interactions, compliance, and oncology approval planning.

Posted 8/6/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesLead💰 $150,000 - $275,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy and submissions for radioligand therapy, with a strong focus on IND/CTA filings and compliance with ICH and GMP regulations. Proven ability to lead teams and mentor staff while engaging with global health authorities.

Highest-signal resume keywords

Regulatory Strategy DevelopmentIND/CTA FilingsLeadership in Regulatory AffairsKnowledge of ICH and GMP RegulationsExperience with Radiopharmaceuticals

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsBriefing Book CompilationGlobal Regulatory StrategyDosimetry ReportingOrphan Drug Pathways

Soft Skills

Strategic ThinkingStrong Writing SkillsHigh-Stakes Negotiation

Industry Keywords

Radioligand TherapyFDAEMAPMDA21 CFR Part 212

About the role

Key responsibilities & impact

Direct the regulatory strategy and submissions for the company's radioligand therapy (RLT) portfolio
Own and compile briefing books for FDA Type B/C meetings and EMA scientific advice
Lead preparation, submission, and maintenance of INDs, CTAs, and amendments
Formulate global regulatory strategies, including accelerated pathways for oncology RLT assets
Represent the company in interactions with FDA, EMA, PMDA, and other health authorities
Prepare responses to health authority queries on RLT topics
Ensure submissions comply with ICH, GMP, and radiation-specific regulations
Collaborate with clinical, CMC, and quality teams on regulatory requirements
Monitor regulatory landscapes for RLT advancements and update strategies
Mentor regulatory staff and build capabilities in RLT submissions

Requirements

What you’ll need

Bachelor's or advanced degree in regulatory science, pharmacy, or related field
10+ years in regulatory affairs
5+ years in leadership
Experience focused on biologics or radiopharmaceuticals
Proven success in IND/CTA filings and interactions with global health authorities
In-depth knowledge of RLT regulations, including dosimetry reporting and orphan drug pathways
Strong writing and strategic thinking skills
Experience in high-stakes negotiations
Knowledge of ICH, GMP, and radiation-specific regulations, including 21 CFR Part 212 for PET drugs

Benefits

Comp & perks

Annual bonus eligibility
Equity participation
Comprehensive benefits program
Market-based, results-driven compensation