Senior Director, Head of Regulatory Affairs
Actinium Pharmaceuticals, Inc., New York, NY, United States
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.
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
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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.
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
#J-18808-Ljbffr