- Amneal Pharmaceuticals (Brookhaven, NY)
- Description: The Manager , Regulatory Compliance , assembles a team for site wise and/or cross departmental discussions, oversees investigation, and completes ... warrant notification to The Food and Drug Administration. The Manager , Regulatory Compliance is responsible...Functions: + Will be the contact person for the FDA and other regulatory agencies in regard… more
- REMOVERY LLC (Austin, TX)
- Regulatory and Compliance Manager About Removery Join us in our journey of normalizing tattoo removal around the world! Removery is an innovative, ... next 5 years. Position Overview: Removery is seeking a Manager of Medical, Regulatory and Compliance...requirements in Australia, Canada, and the United States, including FDA regulations (for the US), and other relevant healthcare… more
- Novo Nordisk (Princeton, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education… more
- Houston Methodist (Houston, TX)
- …**SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH and ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible...International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across… more
- Walmart (Bentonville, AR)
- …direct involvement in executing and building programs expected to guarantee product safety and regulatory compliance . **You'll sweet us off our feet if:** + You ... + You have experience working with government organizations (CPSC, FDA ) + You have the ability to guide insights...analytics needs + You have experience building and scaling compliance programs/processes + You are organized, disciplined, and can… more
- Boehringer Ingelheim (Ridgefield, CT)
- …CFR. Identify and routinely monitor reliable sources from which to obtain product and/or regulatory information. + Review and signature of FDA forms 2253 with ... claims and materials for BI Rx drug promotion for compliance with Food Drug Cosmetic Act (FDCA) and for...of experience in the pharmaceutical industry with experience in Regulatory Affairs. + Manager level: must have… more
- Philips (Chicago, IL)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' ... with the current portfolio in connection with future innovations. + Building FDA regulatory submissions strategy for the products portfolio, providing related… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we are** ... a difference with. **The opportunity** Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager (Parsippany, NJ) to write, review and compile… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Description The Sr Manager Regulatory Affairs represents US regulatory affairs ... primarily for US regulatory filings, ensures technical accuracy, and regulatory compliance . Ensures that applications are executed appropriately and… more
- Takeda Pharmaceuticals (Exton, PA)
- …least one complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products ... best of my knowledge. **Job Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will serve as an… more
- University of Pennsylvania (Philadelphia, PA)
- …University of Pennsylvania, FDA , and GCP standards and guidelines. The Regulatory Project Manager will report directly to the FTDC Clinical Research ... of health and wellness programs and resources, and much more. Posted Job Title Regulatory Project Manager (Department of Neurology) Job Profile Title Manager … more
- AbbVie (South San Francisco, CA)
- …execution of the regulatory strategy. + Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses ... internal cross-functional team who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs, Clinical Development, Legal, &… more
- Danaher Corporation (West Sacramento, CA)
- …lives with diagnostic tools that address the world's biggest health challenges. The Regulatory Affairs Manager for Beckman Coulter Diagnostics is responsible for ... indications within a Therapeutic Area and supports the Sr. Manager Clinical Affairs in the development & execution of...impact on business activities and operations. + Serves as regulatory affairs liaison and interfaces with FDA … more
- AbbVie (Chicago, IL)
- …products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in ... Advise internal customers who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs, Clinical Development, Legal, and… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory ... regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares...for US (PMA, IDE, IDE supplements and annual reports, FDA meetings) and potentially OUS submissions, under supervision. +… more
- Philips (Chicago, IL)
- …regulated markets. + Review and approve advertising, promotional items and labeling for regulatory compliance . + Perform regulatory impact and regulatory ... The Senior Regulatory Affairs Program Manager will play...design process and manufacturing procedures to maintain quality and regulatory compliance . + Reporting to the Head… more
- AbbVie (North Chicago, IL)
- …execution of the regulatory strategy. 7. Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses ... internal cross-functional team who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs, Clinical Development, Legal, &… more
- dsm-firmenich (Princeton, NJ)
- Regulatory Affairs Manager /Personal Care Princeton, NJ,...import to Canada and USA, sunscreen drug listing at FDA and compliance with Proposition 65 and ... centric mindset? Join us in our journey! As a Regulatory Affairs Manager North America (NA), you.... Support submissions related to OTC sunscreen actives at FDA or Health Canada if required and in line… more
- Abbott (Alameda, CA)
- …submission and approval requirements. + Participate in risk benefit analysis for regulatory compliance . + Monitor impact of changing regulations on submission ... their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - Digital Health Technology** will work on-site… more
- University of Washington (Seattle, WA)
- …Research Program and will be instrumental in providing oversight of all research regulatory compliance . This position will not only impact these research ... This position provides significant contributions to research development, implementation and regulatory compliance for the Division of Medical Oncology. The… more
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