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This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division.. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.. Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes care’s projects.. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe. Exciting Opportunity at MSK: Join our team as a Clinical Trials Nurse in our Early Drug Developement department at Memorial Sloan Kettering, We're looking for a dynamic nursing professional eager to showcase compassionate, evidence-based nursing care skills and make a meaningful impact. Participate in an individualized training/orientation program geared to guiding or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC. Location: MSKCC, New York, NY, USA
Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products.. Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements.. Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks.. Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.. Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. The Executive Director, Regulatory Affairs will be responsible for providing strategic leadership and direction for all clinical, development, and operational regulatory activities within Zenas Biopharma. This position reports to the SVP, Global Regulatory Affairs and Medical Writing. Collaborate with cross-functional teams, including clinical development, quality assurance, pharmacovigilance, and legal, to ensure alignment of regulatory strategies, activities and compliance. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific.. Verathon is looking for a Director, Regulatory Affairs to become the newest member of our QA/RA Team located in Bothell, WA. This is an onsite position based in our Bothell WA Headquarters.. The Director, Regulatory Affairs is responsible for managing regulatory strategies for worldwide device and registration of Verathon products, in accordance with product development and business objectives.. Lead, mentor, and develop a team of Regulatory Affairs professionals and contracted clinical study, medical professionals, and other consultants. 8+ years experience in regulatory affairs within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or healthcare products)
This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division.. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs.. Approve regulatory filing strategies based on proposed preclinical, clinical, and manufacturing changes.. Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.. 7+ years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Regulatory Affairs Specialist Kelly® Science & Clinical is seeking Regulatory Affairs Specialist for a direct-hire position at a cutting-edge client in Wyoming.. Their innovation-driven team is committed to transforming clinical care through the development of FDapproved therapies, with a strong focus on stem cell research and commercialization.. As a Senior FDA Regulatory Affairs Specialist, you will play a vital leadership role in navigating the complex regulatory environment surrounding the development and commercialization of cell- and stem-cell-based therapies.. Stem Cell Product Development: Translate stem cell research into viable, FDapprovable commercial products.. Stay ahead of emerging trends in regenerative and cell therapy to drive innovation.
Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products. Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements. Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks. Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development. Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life.. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it.. Exciting Opportunity at MSK: Join our team as a Clinical Trials Nurse in our Early Drug Developement department at Memorial Sloan Kettering, We're looking for a dynamic nursing professional eager to showcase compassionate, evidence-based nursing care skills and make a meaningful impact.. Participate in an individualized training/orientation program geared to guiding or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC.. Location: MSKCC, New York, NY, USA
Empowering Digital Health & Medical Device Organizations Across the US | Engineering (Software, Mechanical) Quality Assurance, Regulatory Affairs.. We are currently seeking a Regulatory Affairs Manager with a minimum of 5 years of experience to join their team in Massachusetts.. Background in regulatory affairs for capital price equipment such as MRI/CT scanners, surgical robots, radiation therapy equipment, or similar advanced technologies.. Get notified about new Regulatory Affairs Manager jobs in Massachusetts, United States.. Associate Director, Regulatory Affairs CMC Senior Manager, Regulatory Affairs Device Associate Director, Global Regulatory Affairs Regulatory Affairs CMC Specialist - Contract Bedford, MA $180,000.00-$200,000.00 1 week ago
Tennessee Oncology is seeking a Director for a new Phase I unit in Chattanooga.. This Phase I unit is part of a larger Phase I program within the Greco-Hainsworth Centers for Research at Tennessee Oncology and part of a regional hub for clinical research.. The Director will be supported by a robust clinical trials infrastructure, including study start-up, regulatory, contract and budgeting, data management, research nursing, pharmacy, and quality.. Tennessee Oncology is built on a foundation of clinical excellence, compassionate support, and commitment to helping our patients through exceedingly challenging times in their lives.. The practice offers Hematology/Medical Oncology, Gynecologic Oncology, Radiation Oncology, Breast Surgery, Palliative Care, and Clinical Trial & Research Programs.
Kelly® Science & Clinical is seeking a Director of Regulatory Affairs for a fulltime, Direct Hire role with a pharmaceutical client based in San Fran Bay area. Position Overview: The Global Regulatory Affairs Director will play a pivotal role in leading and managing our global regulatory strategy to ensure the successful approval and commercialization of our promising HBV small molecule drug. Monitor changes in the regulatory landscape and assess their impact on ongoing and future drug development activities. BS/MS/PhD in Life Sciences, Pharmacology, Pharmacy, or a related degree.. In-depth knowledge infectious disease related therapeutic areas is a plus.
We are hiring a Director, Regulatory Affairs to work on-site at our Medical Device client in Portland. Develop and execute regulatory strategies for new and existing medical devices to ensure compliance with global regulatory requirements (FDA, EMA, MDR, etc.. Monitor regulatory changes and update internal teams regarding potential impacts on product development and market access. Experience in manufacturing or quality assurance in an FDregulated setting, with an in-depth understanding of cGMP, QSR, MDR, and ISO13485 standards. Proven experience with 510(k) submissions and international regulatory requirements (CE marking, EU MDR, etc
Are you fluent in CPT codes, EOBs, and insurance follow-ups?. If you're the kind of person who can chase down a claim with laser focus and still laugh with your team over lunch — we want YOU. We’re a fun-loving, fast-moving healthcare team looking for a Billing & Collections Specialist who knows the medical billing ropes and thrives in a team that works hard and has a blast doing it.. Submit accurate insurance claims and follow up on unpaid or denied claims. ~ Familiarity with EMR/EHR systems and medical billing software. ~ Solid understanding of medical coding (CPT, ICD-10) and claims processing
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. Rotating weekends Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. schedule Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. schedule Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. schedule Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems