Senior Director, Head of Regulatory Affairs

Actinium Pharmaceuticals·
Hybrid | New York, NY (Hybrid)
2w ago
Full-timeSeniorRegulatory AffairsOncologyRadiopharmaceuticalsPhD
Market Rate — Natural Sciences Managers
25th
$120K
Median
$158K
75th
$205K

BLS 2024 data (national)

Description

As Head of Regulatory Affairs, you will define and execute regulatory strategy for Actinium’s oncology portfolio, guiding programs through early and late-stage development and toward U.S. and international approvals. You will serve as Actinium’s primary regulatory authority in interactions with the FDA and global agencies, while building regulatory frameworks that support accelerated development pathways, orphan indications, and novel trial designs. Key Responsibilities include developing and executing global regulatory strategies, identifying regulatory risks, leading and overseeing all regulatory submissions, ensuring regulatory excellence, collaborating with various departments, driving continuous improvement, and representing Regulatory Affairs across teams.

Requirements

MS, PhD, or MD in Life or Health Sciences; 15+ years of pharmaceutical/biotechnology experience, including 10+ years in Regulatory Affairs; Experience in solid tumor oncology, Biologics, and targeted radiotherapy/radiopharmaceuticals; Proven track record leading IND, NDA, and BLA submissions; Deep knowledge of U.S. and global regulatory environments; Ability to support orphan disease programs and accelerated approval pathways; Strong leadership and communication skills; Ability to operate independently and drive results.
Actinium Pharmaceuticals

Actinium Pharmaceuticals

PHARMACEUTICAL

Targeted Radiotherapy

LocationNY - New York
Open Jobs5
Neurology
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