Head of Regulatory Affairs

Company:

Actinium Pharmaceuticals, Inc. develops Antibody Radiation Conjugates, or ARCs, and targeted radiotherapies intended to meaningfully improve survival for patients with relapsed or refractory cancer who have failed existing therapies. We are deploying our technology platform, which we believe to be industry-leading, and intellectual property with over 235 issued and pending patents worldwide, to develop ARCS and next-generation radiotherapies against validated cancer targets. Actinium’s strategy is to build an integrated, specialty radiotherapeutics company using the power of our platform to deliver new treatment options for patient populations living with high unmet medical needs in hematology and oncology.

Our product candidates, Iomab-B and Actimab-A, have the potential to improve outcomes for patients with relapsed or refractory acute myeloid leukemia (r/r AML) and address the significant unmet need for better outcomes from treatment with therapeutics or from undergoing a bone marrow transplant. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium plans to advance with a potential strategic partner in the U.S. following completion of FDA interactions. Actimab-A is a targeted therapy that has demonstrated the potential to extend survival outcomes for people with r/r AML and is poised for advanced development in collaboration with the National Cancer Institute. We are also developing our Iomab-ACT program, a next generation conditioning program for rapidly growing cell and gene therapies, with FDA clearance of an IND to study Iomab-ACT as targeted conditioning prior to commercial CAR-T therapy and an IND for an investigator-led clinical trial for Iomab-ACT prior to a bone marrow transplant for patients with sickle cell disease.

Our R&D capabilities have the potential to yield differentiated, high-value ARC programs that demonstrate our experience across multiple validated cancer targets and isotopes and cover broad areas of focus leveraging our clinical development experience across hematology, targeted conditioning, solid tumors, and next generation ARCs.

Job Overview:

The incoming Head of RA will be a leader and key member of a dynamic team who is responsible for developing, directing and implementing the regulatory strategy for several programs with a focus on unmet medical needs in oncology. They will identify the key strategic regulatory drivers for early and late stage programs for submissions (from IND to BLA) to US and international regulatory agencies. This position also will be responsible for developing, establishing and maintaining effective relationships with regulatory agencies, especially the FDA, EMA and overseeing all Regulatory Affairs activities. The incoming candidate must have significant regulatory expertise in Oncology drug development with a demonstrated track record of success in terms of biologics drug approvals.

Key Responsibilities:

Develop and implement Regulatory Affairs strategies and tactical work plans during clinical development and in preparation for the anticipated US filings

Identifying and assessing regulatory risks, understanding global imperatives including market-related drivers

Accountability for overseeing regulatory submissions for the oncology portfolio, including the associated communication strategy to all regulatory authorities.

Ensure that sound regulatory practices are fully integrated into pre-clinical, clinical and technical submissions, and will ensure that all documents submitted to regulatory agencies are appropriately reviewed to ensure they are complete, scientifically accurate, and of high quality

Contribute to the creation and implementation of development plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications, delivering regulatory approval and reimbursement for all key indications

Act as a credible, influential, respected spokesperson during interactions with US and international regulatory agencies, and ensure appropriate, proactive communication with agencies to assure expedient and efficient review and approval of submissions

Monitor and anticipate regulatory & Scientific Advances, novel end-points, innovative clinical trial designs and regularly brief company management

Present and defend regulatory plans to Senior Management.

Lead the preparation and management of timely regulatory submissions, including INDs, briefing documents, clinical protocols, BLAs, fast-track/breakthrough/accelerated approval/orphan drug applications.

Fulfil all requirements for ensuring all reporting obligations are met, including amendments, annual reports to FDA, safety and quality reports

Collaborate with Medical to manage the regulatory aspects of the company Pharmacovigilance system including the establishment and review of SOPs and providing the regulatory oversight of the system managements and reporting requirements.

Collaborate with Product Development, Manufacturing and Quality to manage regulatory aspects of all CMC activities. Perform regulatory evaluation of CMC change controls.

Participate or lead regulatory interactions with and presentations to US FDA and other regulatory agencies

Review and approval of Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, and ISS.

Represent Regulatory Affairs on cross-functional teams. Interact collaboratively with CMC, clinical, pre-clinical, supply chain, operations and other functional management as they impact the quality of products and operations

Evaluate and approve documentation for regulatory filings.

Use considerable analytical and judgment skills to drive continuous improvements.

Qualifications:

• MS/PhD or MD in Life/Health Sciences.
• A proven leader with a minimum of 15 years pharmaceutical/biotechnology industry experience in multiple phases of development (must have both large and small company experience), 10 years regulatory experience in biotech programs.MUST HAVE Solid Tumor ONCOLOGY EXPERIENCEMUST HAVE BIOLOGICS EXPERIENCERecent experience of IND, NDA and BLA submissions a must.
• Experience with development programs of radioligand treatments and theranostics is a plus.
• Deep knowledge and understanding of drug development process, regulatory requirements and environment, especially in the US.
• Demonstrate strategic thinking and implementation in overall drug development, with experience in orphan diseases.
• Demonstrated strategic capability and ability to see the overall, 'big' picture, along with examples of showing courage and confidence to lead and implement change
• Ability to read, analyse and interpret complex regulatory documents and to respond effectively to sensitive inquiries or complaints
• Able to drive strategic thinking and plans for successful regulatory outcomes.
• Dynamic individual with excellent written and communication skills.
• Ability to set priorities, work independently and deliver results in a timely manner.
• Experience in interfacing with regulatory authorities.
• Strong planning, organizational and leadership skills.
• Strong interpersonal skills and the ability to skillfully and appropriately manage, develop and mentor personnel in a matrix environment.
• Attention to detail.
• Thorough understanding of the FDA (biologics division), including experience in PAI readiness
• Results oriented. Strong initiative, accountability and willingness to take ownership and drive projects to completion
• Experience in radiopharmaceuticals is a major plus

Compensation will be commensurate with experience. Actinium offers competitive base salaries, performance bonuses, equity incentive plans, 401(K) with company matching and comprehensive health benefits.