Regulatory Affairs Director
2 weeks ago
Our client, a global leader in the development and commercialization of robotic systems for advanced surgical interventions, seeks a seasoned Director of Regulatory Affairs to support their R&D team.
Located in the greater San Francisco Bay area, this role requires relocation and on-site presence for 2+ days a week.
Key Responsibilities:- Lead New Drug Application (NDA) preparation activities in collaboration with CROs and internal development teams.
- Develop and execute regulatory plans tailored to the specific needs of small molecule-focused imaging agent drug programs.
- Oversee regulatory submissions through NDA and post-approval commitments, ensuring adherence to regulatory requirements and guidelines.
- Support End of Phase (EOP) Type B meetings and collaborate with cross-functional teams to develop strategies and briefing materials.
- Provide leadership of the regulatory function, interfacing with Clinical, Quality Assurance, and CMC teams.
This is an exciting opportunity to join a dynamic team and contribute to the development of innovative robotic systems for patient care.
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Regulatory Affairs Director
1 month ago
Philadelphia, Pennsylvania, United States HealthCare Recruiters International Full timeDirector of Regulatory AffairsOur client, a pioneering developer of robotic systems for advanced surgical interventions, seeks a seasoned Director of Regulatory Affairs to spearhead regulatory planning and submissions for their small molecule-focused imaging agent drug program.Located in the San Francisco Bay area, this role requires on-site presence 2+ days...
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Regulatory Affairs Director
3 weeks ago
Philadelphia, Pennsylvania, United States HealthCare Recruiters International Full timeDirector of Regulatory AffairsOur client, a global leader in the development and commercialization of robotic systems for advanced surgical interventions, seeks a seasoned Director of Regulatory Affairs to support their R&D team.This role will focus on developing effective regulatory strategies for small molecule-focused imaging agent drug programs.The ideal...
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Regulatory Affairs Director
4 weeks ago
Philadelphia, Pennsylvania, United States The O'Connor Group Full timeAbout the PositionWe are seeking a highly motivated and experienced Director of Regulatory Affairs to join our team at The O'Connor Group. This individual will report directly to our Chief Scientific Officer and be responsible for developing and implementing our comprehensive regulatory strategy across pipelines and markets.The successful candidate will have...
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Associate Director, Oncology Regulatory Affairs
2 weeks ago
Philadelphia, Pennsylvania, United States GSK Full timeJob SummaryWe are seeking a highly skilled and experienced Associate Director, Oncology Regulatory Affairs to join our team at GSK. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies to support the development and approval of oncology products.Key ResponsibilitiesDevelop and implement...
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Senior Director of Global Regulatory Affairs CMC
4 weeks ago
Philadelphia, Pennsylvania, United States Adaptimmune Full timeJob Title: Senior Director of Global Regulatory Affairs CMCAdaptimmune is a leading biotechnology company that is revolutionizing the field of cell therapy. We are seeking a highly experienced Senior Director of Global Regulatory Affairs CMC to join our team.Job SummaryThe Senior Director of Global Regulatory Affairs CMC will be responsible for leading our...
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Senior Director of Global Regulatory Affairs CMC
3 weeks ago
Philadelphia, Pennsylvania, United States Adaptimmune Full timeJob Title: Senior Director of Global Regulatory Affairs CMCAdaptimmune is a pioneering cell therapy company that has revolutionized the field of cancer treatment. As a Senior Director of Global Regulatory Affairs CMC, you will play a critical role in shaping the company's regulatory strategy and ensuring compliance with global regulations.Key...
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Philadelphia, Pennsylvania, United States Adaptimmune Full timeJob Title: Senior Director of Global Regulatory Affairs CMCAdaptimmune is a pioneering cell therapy company that is revolutionizing the treatment of cancer. We are seeking a highly experienced Senior Director of Global Regulatory Affairs CMC to lead our regulatory affairs team and ensure the successful development and approval of our cell and gene therapy...
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Philadelphia, Pennsylvania, United States Adaptimmune Full timeJob Title: Associate Director of Global Regulatory Affairs CMCAdaptimmune is a leading biotechnology company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.Job...
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Philadelphia, Pennsylvania, United States Adaptimmune Full timeJob SummaryWe are seeking a highly experienced Senior Director of Global Regulatory Affairs CMC to lead our CMC sub-team within Global Regulatory Affairs. This role will provide regulatory leadership and oversight in support of our product portfolio, including CMC regulatory strategies, development plans, and risk assessments.Key ResponsibilitiesProvide...
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Philadelphia, Pennsylvania, United States Adaptimmune Full timeJob Title: Associate Director, Global Regulatory Affairs CMCAdaptimmune is a pioneering cell therapy company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.Our...
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Philadelphia, Pennsylvania, United States Adaptimmune Full timeJob Title: Associate Director of Global Regulatory Affairs CMCAdaptimmune is a pioneering cell therapy company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...
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Regulatory Affairs Specialist
3 weeks ago
Philadelphia, Pennsylvania, United States GSK Full timeAbout the RoleWe are seeking a highly motivated Regulatory Affairs professional to join our CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Group. As a Regulatory Project Manager (CMC), you will be responsible for providing CMC support to a defined portfolio of marketed drug substances and products (small molecules) for global markets.Key...
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Director of Federal Affairs
3 weeks ago
Philadelphia, Pennsylvania, United States InsideHigherEd Full timeJob Title: Director of Federal AffairsThe University of Pennsylvania seeks a highly skilled and experienced Director of Federal Affairs to join its Office of Government and Community Affairs. This key role will be responsible for developing and implementing comprehensive strategic advocacy programs to advance the University's interests with the federal...
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Federal Affairs Director
1 month ago
Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full timeJob SummaryThe Director of Federal Affairs in the Office of Government and Community Affairs at the Trustees of the University of Pennsylvania advances the University's interests with the federal government related to our mission of education, research, and service.Key ResponsibilitiesAdvise University leadership on developments in federal government,...
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Senior Regulatory Affairs Specialist, CMC
5 hours ago
Philadelphia, Pennsylvania, United States Adaptimmune Full timeJob SummaryAdaptimmune is a leading cell therapy company with a strong presence in the UK and US. We are seeking a highly experienced Senior Regulatory Affairs Specialist to join our Global Regulatory Affairs team. The successful candidate will be responsible for developing and executing global Chemistry, Manufacturing, and Control (CMC) regulatory...
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Director of Federal Affairs
3 days ago
Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full timeJob SummaryThe Director of Federal Affairs at the Trustees of the University of Pennsylvania plays a critical role in advancing the University's interests with the federal government. This position requires a deep understanding of higher education policy and the ability to analyze potential opportunities and impacts of proposed federal legislation and...
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Director of Federal Affairs
3 weeks ago
Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full timeJob SummaryThe Director of Federal Affairs in the Office of Government and Community Affairs at the University of Pennsylvania advances the University's interests with the federal government related to our mission of education, research, and service. The Director utilizes professional knowledge of higher education policy and established contacts to analyze...
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Alumni Affairs Director
1 month ago
Philadelphia, Pennsylvania, United States Temple University Full timeJob SummaryThe Associate Director of Alumni Affairs is a key member of the Law School Development and Alumni Affairs team, responsible for managing and implementing all aspects of Law School alumni affairs to advance a strategic alumni engagement plan.Key ResponsibilitiesDevelop and execute a comprehensive system for alumni engagement and email marketing...
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Alumni Affairs Director
4 weeks ago
Philadelphia, Pennsylvania, United States Temple University Full timeJob SummaryThe Associate Director of Alumni Affairs is a key member of the Law School Development and Alumni Affairs team, responsible for managing and implementing all aspects of Law School alumni affairs to advance a strategic alumni engagement plan.Key ResponsibilitiesDevelop and execute a comprehensive system for alumni engagement and email marketing...
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Executive Director of Legal Affairs
3 weeks ago
Philadelphia, Pennsylvania, United States InsideHigherEd Full timeJob SummaryWe are seeking an experienced and skilled Executive Director of Legal Affairs to join our team at the Abramson Cancer Center. As a key member of our leadership team, you will be responsible for overseeing legal matters for the cancer center and reporting directly to both the ACC Director and the General Counsel of the University of...