Actinium Pharmaceuticals, Inc. · 15 hours ago
Senior Director, Head of Regulatory Affairs
New York, United States
Full-time
Hybrid
Director/Executive
15+ years expActinium Pharmaceuticals is a leader in the radiopharmaceuticals sector, focusing on innovative oncology solutions. The Senior Director, Head of Regulatory Affairs will lead regulatory strategy for oncology programs, ensuring successful global regulatory outcomes from IND through BLA while collaborating with various departments to drive compliance and excellence.
BiotechnologyClinical TrialsHealth DiagnosticsPharmaceutical
Responsibilities
Develop and execute global regulatory strategies across early- and late-stage oncology programs (IND through BLA)
Identify regulatory risks and proactively define mitigation strategies aligned with development and commercial objectives
Lead and oversee all regulatory submissions, including INDs, briefing documents, clinical protocols, BLAs, and expedited programs (Fast Track, Breakthrough Therapy, Accelerated Approval, Orphan Drug)
Act as a senior regulatory spokesperson with the FDA, EMA, and other global regulatory authorities; lead and participate in agency meetings and negotiations
Ensure regulatory excellence across preclinical, clinical, and CMC activities, including review and approval of all regulatory documents for quality, accuracy, and compliance
Partner with Clinical Development to integrate regulatory strategy into development plans, trial designs, and endpoint selection
Collaborate with Medical to provide regulatory oversight of pharmacovigilance systems, safety reporting, and SOPs
Collaborate with Manufacturing, Quality, and Product Development on CMC regulatory strategy, including evaluation of change controls
Monitor and communicate emerging regulatory, scientific, and policy trends, novel endpoints, and innovative trial designs to senior leadership
Present regulatory strategies, risks, and recommendations to Senior Management
Ensure compliance with all ongoing regulatory obligations, including amendments, annual reports, safety reports, and global filings
Represent Regulatory Affairs on cross-functional teams, working closely with Clinical, CMC, Preclinical, Supply Chain, and Operations
Drive continuous improvement through strong analytical judgment and regulatory best practices
Qualification
Required
MS, PhD, or MD in Life or Health Sciences
15+ years of pharmaceutical/biotechnology industry experience, including 10+ years in Regulatory Affairs
Experience across both large and small biotech/pharma organizations
Required expertise: Solid tumor oncology, Biologics, Targeted radiotherapy / radiopharmaceuticals
Proven track record leading IND, NDA, and BLA submissions
Deep knowledge of U.S. and global regulatory environments, including FDA biologics division and PAI readiness
Strategic mindset with the ability to translate complex science into executable regulatory plans
Experience supporting orphan disease programs and accelerated approval pathways
Strong leadership, communication, and cross-functional influence skills
Ability to operate independently, prioritize effectively, and drive results in a fast-paced environment
Demonstrated success interfacing directly with regulatory authorities
Results-oriented, detail-focused, and accountable leader with a hands-on approach
Preferred
Experience with radioligand therapies strongly preferred
Benefits
Competitive compensation including base salary
Performance bonus
Equity
401(k) with company match
Comprehensive benefits
Company
Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals (NYSE: ATNM) is focused on developing innovative targeted radioimmunotherapies for the treatment of advanced cancers.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknownKey Investors
National Institutes of Health
2023-10-04Grant
Leadership Team
Steve O' Loughlin
Chief Financial Officer
Recent News
2025-12-13
2025-12-12
2025-12-01
Company data provided by crunchbase