Senior Director​/VP, Head of Regulatory Affairs

.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) radio therapies 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 potentia

l.
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 B

nity

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 approv

als.
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 des

• lities
  
  Develop and execute global regulatory strategies across early- and late-stage oncology programs (IND throug
• h BLA)
  Identify regulatory risks and proactively define mitigation strategies aligned with development and commercial obje
• ctives
  
  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 negoti
• ations
  
  Ensure regulatory excellence across preclinical, clinical, and CMC activities, including review and approval of all regulatory documents for quality, accuracy, and comp
• liance
  
  Partner with Clinical Development to integrate regulatory strategy into development plans, trial designs, and endpoint sel
• ection
  
  Collaborate with Medical to provide regulatory oversight of pharmacovigilance systems, safety reporting, an
• d SOPsCollaborate with Manufacturing, Quality, and Product Development on CMC regulatory strategy, including evaluation of change co
• ntrols
  
  Monitor and communicate emerging regulatory, scientific, and policy trends, novel endpoints, and innovative trial designs to senior lead
• ership
  
  Present regulatory strategies, risks, and recommendations to Senior Mana
• gement
  
  Ensure compliance with all ongoing regulatory obligations, including amendments, annual reports, safety reports, and global f
• ilings
  
  Represent Regulatory Affairs on cross-functional teams, working closely with Clinical, CMC, Preclinical, Supply Chain, and Oper
• ations
  
  Drive continuous improvement through strong analytical judgment and regulatory best pra

• u BringMS, PhD, or MD in Life or Health S
• ciences
  10 – 15 years of pharmaceutical/biotechnology industry experience, including 5
  -10 years in Regulatory
• Affairs Experience across both large and small biotech/pharma organi
• zations
  
  Required expertise:
  Solid tumor oncology, Biologics, Targeted radiotherapy / radiopharmace
• uticals
  
  Proven track record leading IND, NDA, and BLA subm
• issions
  
  Experience with radioligand therapies and theranostics strongly pr
• eferred
  
  Deep knowledge of U.S. and global regulatory environments, including FDA biologics division and PAI re
• adiness
  
  Strategic mindset with the ability to translate…