- Dow (Houston, TX)
- At a glance Position: FDA Product Regulatory Manager Primary Location:Midland (MI, USA), Michigan, United States of America Additional Locations: Freeport (TX, ... Type:Regular Workplace Type:Remote or Hybrid or Onsite Apply Now (https://dow.wd1.myworkdayjobs.com/ExternalCareers/job/Midland-MI-USA/ FDA -Product- Regulatory -Manager\_R2060938/apply) Return to Job Finder At Dow,… more
- BeOne Medicines (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- RWJBarnabas Health (West Orange, NJ)
- …years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting + Comprehensive knowledge ... Assistant Vice President of Legal Affairs, Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas… more
- J&J Family of Companies (Horsham, PA)
- …subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines ... pharmaceutical or biopharmaceutical industry is required. + Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …two (2) specialized areas of pharmaceutical law, one of which must be FDA Regulatory (eg, patient support programs, market access, patient assistance support) ... programs, access, Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in the… more
- Xcelerate Solutions (Frederick, MD)
- …trend knowledge points and risks through the medical portfolio + Track and trend FDA regulatory intelligence + Assist with full lifecycle project management and ... Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking...for pharmaceutical development and within the constraints of the FDA approval process + Plan and provide input to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory relevant ... and/or supplemental applications and post marketing reports per US FDA regulations. Responsible contact for US regulatory ...US FDA regulations. Responsible contact for US regulatory relevant topics, and primary liaison to FDA… more
- IQVIA (Washington, DC)
- …required; advanced degree preferred. * 5-10 years working within information/cyber security/ FDA cyber Regulatory required. Engineering or science background with ... strategies to internal team members and clients. * Possesses US regulatory experience/fluency with FDA regulations. * Experience with FDA pre- and… more
- Abbott (Santa Clara, CA)
- …legislation, regulations, and guidances + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical ... and maintenance in regulated environments. + In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485,...+ In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485, GDPR) relevant to software products,… more
- Schwan's Company (Minneapolis, MN)
- …and Preventive Controls Qualified Individual (PCQI), providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/ FDA ), and ... leadership: Act as the main point of contact for regulatory agencies including FSIS, FDA , CFIA, and...of contact for regulatory agencies including FSIS, FDA , CFIA, and State/Military authorities. Lead corporate recall processes,… more
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