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Join to apply for the Senior Regulatory Affairs Manager role at Katalyst CRO . Location: Cambridge, MA Responsibilities Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle. Ensure strategic alignment with the Clinical Development Plan (CDP) and nonclinical development plan with input from clinical and nonclinical Subject Matter Experts (SMEs), respectively, a…
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Responsibilities The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM…
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Onsite Minneapolis, Minnesota, United States of America Jacksonville, Florida, United States of America Fort Worth, Texas, United States of America Memphis, Tennessee, United States of America Lafayette, Colorado, United States of America Full time R70011 We anticipate the application window for this opening will close on - 25 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Ou…
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Onsite Minneapolis, Minnesota, United States of America Jacksonville, Florida, United States of America Fort Worth, Texas, United States of America Memphis, Tennessee, United States of America Lafayette, Colorado, United States of America Full time R70011 We anticipate the application window for this opening will close on - 25 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Ou…
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Onsite Minneapolis, Minnesota, United States of America Jacksonville, Florida, United States of America Fort Worth, Texas, United States of America Memphis, Tennessee, United States of America Lafayette, Colorado, United States of America Full time R70011 We anticipate the application window for this opening will close on - 25 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Ou…
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Hybrid RTP, NC Full time R05189 California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdfpage=9) . The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies…
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You…
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You…
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Regulatory Affairs Manager - Diabetes Care (on-site)
Alameda Pt, Alameda County
2026-05-23T18:43:55Z
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You…
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Regulatory Affairs Manager, Obesity and Related Conditions
Washington, D.C., US
2026-07-02T22:45:54Z
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Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep p…
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Job Description Job Description The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic regulatory leadership to support business growth, innovation, customer conversions from synthetic dyes to natural colors, and market expansion while ensuring compliance with all applicable food, beverage, pet food, nutraceutical, and biotechnology regulations. As the r…
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Regulatory Affairs Manager A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy…
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Regulatory Affairs Manager A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy…
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Description The Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions as well as CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs. Responsibilities: Provide critical support in writing and editing technical documents to support submissions for i…
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About the role Regulatory Affairs Manager lead all aspects of Regulatory Affairs related to medical devices regulatory submissions and submissions for global markets, supports all aspects of the Quality Management System, design and development, and distribution. This position works with internal and external teams. The Regulatory Affairs Manager reports to the Director of CA/QA/RA. What you'll do Act as backup for the Director of Quality and Regulatory Affairs and assist in audit activities (s…
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Regulatory Affairs Manager A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Thera…
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Regulatory Affairs Manager A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy…
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Overview CAB Enterprises, Inc. proudly serves as the exclusive distributor of Electrolit in the United States. Electrolit is owned by Grupo Pisa, Latin America's premier pharmaceutical company with over 80 years of experience. Electrolit has become a leader in premium hydration beverages. Since Electrolit entered the US in 2015, we have increased Electrolit's visibility in the U.S. market, by building on the brand’s rich legacy that began in 1950 as a hydration solution for children. With a ste…
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Regulatory Affairs Manager Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description Primary Role: Under the general direction of the CMC Regulatory Af…
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Regulatory Affairs Manager Mindlance Clinical has been providing scientific and clinical research staffing and outsourcing services to leading pharmaceuticals, biotechnology, medical devices and CROs for over a decade. Due to the ever changing complexities associated with supporting a successful study from the inception of drug development planning to regulatory submissions to market, we understand it is the talent and quality people that make the difference. With the additional emphasis placed…
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