- Sanofi Group (Framingham, MA)
- **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, ... was possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up** for US … more
- Kelly Services (Gillette, WY)
- …team is committed to transforming clinical care through the development of FDA -approved therapies, with a strong focus on stem cell research and commercialization. ... to shaping the future of healthcare. As a **Senior FDA Regulatory Affairs Specialist** , you will play a...collaborate with internal teams and external partners to ensure FDA compliance and successful product development from concept to… more
- Bayer (NJ)
- …efficient submissions of high-quality dossiers, driving Food and Drug Administration ( FDA ) communications and negotiations to achieve timely product approvals with ... products, indications or projects, working closely with cross-functional colleagues and the FDA ; + Acts as a critical collaborative partner with the Global… more
- Novo Nordisk (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... to accomplish company goals. External relationships may include interaction with FDA personnel regarding assigned projects and roles. Essential Functions + Compile… more
- Boehringer Ingelheim (Ridgefield, CT)
- …draft CCDS. + Provide US guidance to the global team on FDA submissions, meetings, and pediatric development requirements, including documentation preparation. (3) ... teams during development, registration, and marketing approval considering regulatory precedence and FDA guidance. + Contribute to US RA efforts on draft labeling… more
- Chewy (Belton, MO)
- …drug products across our operations! This role will focus on ensuring alignment to FDA directives at both the local and federal levels and inspecting sites to verify ... do:** + Conduct comprehensive site inspections to assess adherence to FDA regulations and Chewy's internal food safety policies, identifying non-compliance areas… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …frameworks, Agile SDLC, experience with cross functional team transactions, and various FDA SW related guidance's and industry best practices. The role involves ... and execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the… more
- BeOne Medicines (San Mateo, CA)
- …The individual will have extensive experience with the United States FDA , oncology division, leading key interactions including supporting advisory committee (ODAC) ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge...and risk assessments, critical issue management and advice on FDA interactions. + Oversees the preparation of NA regulatory… more
- Merck (Rahway, NJ)
- …a trusted regulatory center of excellence and lead successful interactions with FDA regarding select US topics, primarily including drug shortages, user fee ... In this role, you will facilitate interactions with the FDA , monitor changes in regulations, and engage with external...of information + Facilitating execution of direct interactions with FDA + Monitoring the regulatory landscape and the effect… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …Grifols USA. Generates records to comply with regulatory requirements, (cGMP QSR/ FDA /EN ISO Quality standards, Good Distribution Practices and Internal Quality ... with the rules and regulations of the regulatory agencies ( FDA 21CFR, PIC/s GDP & EN ISO 9001) and...matrixed environment within a pharmaceutical, medical device, GMP or FDA regulated industry. + Must be able to demonstrate… more
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