Senior Director / Head of Regulatory Affairs
Location: Hybrid | New York, NY
Reporting to: VP, Head of Solid Tumor Clinical Development
Why This Role. Why Actinium.
Radiopharmaceuticals are redefining oncology — and Actinium Pharmaceuticals is one of the category leaders shaping what comes next.
Actinium is advancing a differentiated pipeline of targeted Actinium-225 (Ac-225) radiotherapies across solid tumors and hematologic malignancies, supported by deep radiochemistry expertise, proprietary manufacturing capabilities, and a growing clinical footprint. Our programs span first-in-class solid tumor assets, late-stage hematology programs, and platform technologies with global regulatory potential.
We are seeking a Senior Director, Head of Regulatory Affairs to lead regulatory strategy across multiple oncology programs, with a strong emphasis on solid tumors, biologics, and targeted radiotherapy. This is a high-visibility leadership role, partnering closely with Clinical, CMC, Medical, and executive leadership to drive successful global regulatory outcomes from IND through BLA.
The Opportunity
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
- 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
What You Bring
- 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
- Experience with radioligand therapies strongly preferred
- 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
Why Join Actinium
- Leadership role in a category-defining radiopharmaceutical company
- Opportunity to shape regulatory strategy for first-in-class solid tumor programs
- Direct impact on late-stage and pivotal clinical programs
- Competitive compensation including base salary, performance bonus, equity, 401(k) with company match, and comprehensive benefits