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This unique opportunity is at a prestigious facility looking to hire a traveling therapist.. This exciting area offers many recreational activities.. As a premier travel therapy company, Host Healthcare offers top pay, excellent benefits, and personalized service.. The ideal candidate for this position will be dedicated to providing patients with the highest level of service.. The ideal candidate will also be knowledgeable in Medicare, Medicaid, and private insurance, as well as the ability to complete relevant insurance documentations.
This strategic and hands-on role will be responsible for overseeing regulatory operations & submissions, contributing to global RA strategy and ensuring timely, high-quality submissions in alignment with global health authority requirements.. Contribute to continuous process improvement within regulatory operations.. Minimum 8 years in the pharmaceutical or biotech industry, including 3+ years in regulatory affairs with direct IND/CTA/NDA/MAA experience.. Pharmaceutical Manufacturing and Biotechnology Research. Associate Director, Regulatory Affairs Vaccines CMC
Participating in investigator meeting planning and execution, including on-site initiation meetings.. Understanding of therapeutic principles and clinical research methodologies.. Knowledge of scientific literature and data interpretation.. Experience in neurology or rare diseases clinical trials.. Strong business acumen, understanding multidisciplinary drug development functions.
Proven track record with U.S. and global regulatory submissions, including PMA and 510(k).. Director/Senior Director, Corporate Counsel. Head, Ethics & Compliance, Global Oncology BU. Ethics & Compliance Business Partner, Dermatology. Executive Director, Senior Corporate Counsel
Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS).. Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.. The Associate Director, Regulatory Affairs will help drive forward our regulatory strategy and operational activities related to Dyne’s muscle disease programs.. Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g., Fast Track, Orphan Drug Designation, etc).. Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development is a plus.
As the Development lead, the Senior Director will work closely with senior leaders from Commercial, Technical Operations, Medical, and Corporate Strategy to ensure alignment on key objectives and the seamless integration of R&D strategies across the drug development process.. Provide strategic oversight for R&D activities, including drug discovery, preclinical research, and clinical development, ensuring they align with the company’s long-term objectives.. Serve as the primary conduit between R&D and other key functions (Commercial, Technical Operations, Medical, Corporate Strategy) to ensure consistent communication and alignment on program direction and execution.. Deep knowledge of drug discovery and development processes, including preclinical research, clinical development, regulatory strategies, and lifecycle management as well as pharmacology, toxicology, formulation science, and biostatistics.. Strong understanding of regulatory pathways, including IND/CTA submissions, clinical trial design, and global requirements.
Health IT Specialist Part-Time (Remote) - National. Join to apply for the Health IT Specialist Part-Time (Remote) - National role at IQVIA. This role offers a unique opportunity to be part of a major brand in the US healthcare market as a Health Information Technology Specialist.. The role involves working closely with end users, clinicians, IT, informatics teams, and EHR managers to identify and address patient safety gaps related to EHR systems.. At least 4 years of experience with healthcare software such as Epic, Cerner, Meditech, or within a health system informatics group
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the team's activities from IND-enabling studies and first-in-human (FIH) studies through clinical proof of concept (PoC) trials, and to facilitate post-PoC transitioning to our Otsuka affiliate for global clinical development & commercialization.. Effectively negotiate alignment with Otsuka parent and affiliate organizations on strategy & messaging to produce optimal outcomes from global health authority interactions.. Define and oversee phase-appropriate CMC regulatory strategy for biologics, including CMC regulatory-specific risk mitigation, and ensuring seamless progression from discovery through early clinical development.. Support CMC functions (e.g. Process Development, Analytical Development, Manufacturing and Quality Control) pertaining to the preparation and content of CTA/IMPDs, PPQs, INDs dossiers to ensure timely delivery of final documents to be included in submissions.. 15+ years of global regulatory affairs experience, including at least 5 - 7 years in biologics, with expertise in early-stage development (IND-enabling, FIH, PoC), CMC regulatory strategy, and global compliance.
In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program(s) under your accountability.. By joining our growing and dynamic regulatory affairs team, you’ll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments.. 8+ years of Regulatory Affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development – both big and small company experience is preferred. Demonstrated experience with regulatory programs for products to treat rare diseases and/or unmet medical needs (e.g., orphan products, fast track, breakthrough therapies, PRIME). Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs
Bicara Therapeutics is seeking a proactive and detail-oriented Regulatory Affairs Program Manager to contribute to the development of regulatory strategies and to coordinate regulatory activities across the product lifecycle.. Minimum 2-4 years of experience in regulatory affairs within the biotech or pharmaceutical industry strongly preferred. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β).. Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment.. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types.
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the team’s activities from IND-enabling studies and first-in-human (FIH) studies through clinical proof of concept (PoC) trials, and to facilitate post-PoC transitioning to our Otsuka affiliate for global clinical development & commercialization.. Effectively negotiate alignment with Otsuka parent and affiliate organizations on strategy & messaging to produce optimal outcomes from global health authority interactions.. Define and oversee phase-appropriate CMC regulatory strategy for biologics, including CMC regulatory-specific risk mitigation, and ensuring seamless progression from discovery through early clinical development.. Support CMC functions (e.g. Process Development, Analytical Development, Manufacturing and Quality Control) pertaining to the preparation and content of CTA/IMPDs, PPQs, INDs dossiers to ensure timely delivery of final documents to be included in submissions.. 15+ years of global regulatory affairs experience, including at least 5 - 7 years in biologics, with expertise in early-stage development (IND-enabling, FIH, PoC), CMC regulatory strategy, and global compliance.
Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS).. Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.. The Associate Director, Regulatory Affairs will help drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs.. Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc).. Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus.
Biotechnology Research and Pharmaceutical Manufacturing. Associate Director, Global Regulatory Affairs. Director, Global Regulatory Affairs (GRA) – CMC. Executive Director, Regulatory Affairs & Quality Assurance.. Associate Director, Global Regulatory Affairs, Advertising and Promotion
Novartis has a long term commitment to Global Health including communicable diseases like malaria and non communicable diseases.. Novartis first supported sickle cell disease (SCD) care over 50 years ago with the development of chelators for the management of iron overload.. As a TM Expert for Global Health, you will collaborate with the Therapeutic Area Head or other experienced TM Experts to develop high value decision-strategies for the Translational Medicine component of drug development projects and lead global cross-functional project teams.. In collaboration with research scientists identify, develop and implement strategy for preclinical support of program related objectives; this includes assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications and other relevant activities. Doctoral degree, MD required with clinical subspecialty training preferred in one of the following areas: Hematology or Pediatrics with Sickle Cell expertise; Additional PhD/post-doctoral equivalent research preferred as well as board-certification in relevant subspecialty area.
Our flagship product, SIR-Spheres Y-90 resin microspheres, is a targeted radiation therapy for liver cancer.. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide.. Job Description The Senior Regulatory Affairs Specialist is responsible for: assisting with the preparation of regulatory submissions in order to obtain and maintain the necessary regulatory approvals/clearances/licenses, providing regulatory support to cross-functional initiatives as required, and directing the work of less experienced regulatory staff to extend and develop their skills for the successful global registration and commercialization of Sirtex products.. Prepare and file regulatory submissions with minimal supervision, for countries that have complex requirements such as US FDA (e.g., 510(k), PMA, etc.). Support or lead, as assigned, any regulatory reporting required by Regulatory Agencies.
We are looking to expand our Regulatory Affairs team in the US and are currently looking for an experienced Regulatory Consultant to join us on a permanent basis.. This may encompass projects in various stages of development, from pre-IND through to NDA/BLA filing stage.. Prepare regulatory submissions including clinical trial applications and amendments (IND or CTA), NDA/BLA/MAA dossiers and variations.. Previous hands-on experience working within Regulatory Affairs. We are a forward-thinking regulatory affairs consultancy, DLRC Ltd takes the time to understand individual needs and find creative solutions for any regulatory challenge.
About the role: As a UM Care Manager with eternalHealth you will be a core member at eternalHealth – whose responsibilities will include care management.. Actively perform and comprehensively document member and provider outreach and engagement activities to support complex care management, care coordination, disease management, and transitions of care.. Follow and contribute to eternalHealth’s strategic goals related to population health management, quality improvement, and financial stewardship.. Master’s degree in business administration, healthcare administration, related field, a plus.. As a woman-led company, and one committed to diversity at all levels, we strive for an organization of inclusion and acceptance.
We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.. Formulates and establishes associated regulatory procedures for company in close collaboration with the Sr. Director, Regulatory Affairs and Quality, as well as with Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.). Manage the regulatory release of new products and address any regulatory import/export issues.. Monitor for and lead opportunities with FDA and Health Canada to participate in relevant pilot programs and Experiential Learning Programs.. Develop and deliver training regarding NAM Regulatory Affairs activities for Straumann Group globally and support in cross country projects as needed.
This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology, an unprecedented new drug modality in the US and other global markets.. May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant.. BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.. Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance at least in the US.. A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world.. Principal Regulatory Affairs Specialist. The Digital Healthcare Group is looking for an energetic, Principal Regulatory Affairs Specialist for the development of novel solutions.. Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements. For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls.