- L'Oreal (Clark, NJ)
- …experiences that will change people's lives. As a Principal Scientist, Scientific & Regulatory International Affairs (SRIA) Americas in Regulatory Affairs ... strategic initiatives. International activities: Collaborate with trade associations' international regulatory groups (eg, PCPC) to enhance awareness, ensure… more
- Merck & Co. (Upper Gwynedd, PA)
- …Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance, Microbiology, Molecular Microbiology, ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Michael Page (Skokie, IL)
- …a plus). Additional certifications or training in FDA regulations, GMP, HACCP, or international regulatory standards (eg, ISO, NSF, FSSC) are highly desirable. ... client is redefining the future of health and nutrition. Job Description Regulatory Compliance Oversight: Ensure all products comply with applicable regulations and… more
- Betco Corporation, LTD (Bowling Green, OH)
- Develop, implement and coordinate compliance with federal, state, local and international regulatory requirements applicable to Institution cleaning chemicals, ... and support for the company's compliance activities, day-to-day administration of regulatory matters and promoting sound product stewardship. Able to provide… more
- Medtronic (Irvine, CA)
- …with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining ... US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining … more
- IntePros (Audubon, PA)
- …Regulatory Affairs Associate maintains CE Technical Files and registrations for international Regulatory agencies. This position entails working knowledge of ... IntePros is currently looking for a Regulatory Affairs Associate to join one of our...with development teams while following ISO, CE, FDA and international /local regulations. Experience should demonstrate dependability, flexibility and attention… more
- Lexington Medical (Bedford, MA)
- …devices that include software and hardware systems is helpful. Experience with international regulatory requirements and standards, including MDSAP, EU MDR, and ... required to align with new regulations and requirements including changes to international standards. Serve as the voice of regulatory on cross-functional… more
- Intuitive (Sunnyvale, CA)
- … regulatory agencies on regulatory issues and submissions. *Support international regulatory efforts as needed. *Perform other duties as required. ... Company Description Job Description New Product/Indication Submissions Provide regulatory insight to development, new product introduction, and manufacturing teams… more
- Fortrea (Durham, NC)
- …in a global QA role In-depth knowledge of ICH-GCP, FDA, EMA, and other international regulatory standards Experience directing global audits and regulatory ... Job Overview: This leader will report into the Chief Quality, Regulatory , and Sustainability Officer along with the leaders of the Clinical Pharmacology Services QA… more
- Tandem (San Diego, CA)
- … processes to ensure compliance with regulations set forth by the USFDA, International Regulatory Agencies, and in conformance with Good Manufacturing Practices, ... Learn more at https://www.tandemdiabetes.com/ A DAY IN THE LIFE: The Sr. Regulatory Affairs Specialist II is responsible for developing strategies for worldwide … more
- Abbott (Minneapolis, MN)
- … standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates. Maintains pertinent domestic and ... requirements. Complies with US Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies,… more
- Formation Bio (New York, NY)
- …Understanding of FDA/ international regulations, ICH guidelines, and applicable US/ international regulatory processes related to document preparation and ... (IBs), clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory filings); and… more
- Oshkosh Corporation (Hagerstown, MD)
- …of financial controls and update Sarbanes-Oxley process documentation to reflect international regulatory requirements. Develop and promote globally accessible ... responsibility, with a particular focus on supporting both domestic and international operations. The Lead Finance Analyst will process business transactions across… more
- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/ international regulations as they ... an effective Industrial QMS that provides compliance to relevant international standards, customer requirements and regulatory requirements.Maintains oversight… more
- BitGo (Sioux Falls, SD)
- …with BitGo's global compliance teams to share best practices and support international regulatory requirements. Contribute to the development of strategic ... traditional and crypto platforms. You will drive operational excellence, ensure regulatory compliance, and collaborate across teams to enhance BitGo's Anti-Money… more
- Sundyne (Arvada, CO)
- …instrumentation associated with performance and anti-surge controllers Follow local and international regulatory codes Prepares and reviews skid electrical ... projects with various deadlines and responsibility levels Some travel, including international , required for field support and customer meetings Some travel,… more
- Robinhood (Menlo Park, CA)
- …pre-litigation demand letters, employee charges pending before federal, state, and international regulatory bodies, and employment litigation Structure and draft ... leaders across the company on a broad range of domestic and international business and legal matters including benefits, compensation, immigration, recruiting, tax,… more
- Forge Biologics (Columbus, OH)
- …with applicable regulatory requirements, including FDA, cGMP, and international regulatory requirements Support the development of related documents ... record in supporting MS&T teams Knowledge of FDA, cGMP, and international regulatory requirements Excellent communication, organizational, and interpersonal… more
- curium (Maryland Heights, MO)
- …and regulatory requirements. Must maintain operational compliance with US and international regulatory agencies and guidelines (ie FDA, EU, HC, TGA, PIC/S, ... analytical analysis techniques and statistical quality control. Working knowledge of regulatory (FDA, HC, TGA, EU, ISO, USP, etc.) requirements and applicable… more
- Eisai, Inc (Nutley, NJ)
- …Substantial experience in inspection management. Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of ... clinical trials. Demonstrated ability to operate and influence decision-making processes Effective communication skills Successful track record of supervising employees and managing cross-cultural differences Technical and administrative capabilities to… more
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