- Sanofi Group (Framingham, MA)
- …and roll-out of the Sanofi Quality Management System in line with US FDA cGMP regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi ... **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job...secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity,… more
- Kelly Services (Gillette, WY)
- …research laboratory dedicated to shaping the future of healthcare. As a **Senior FDA Regulatory Affairs Specialist** , you will play a vital leadership ... regulatory teams to meet safety and efficacy standards. ** Regulatory and Compliance Expertise:** + Lead FDA ...standards. ** Regulatory and Compliance Expertise:** + Lead FDA strategy and submission efforts for INDs, IDEs, and… more
- Bayer (NJ)
- …Bayer seeks an incumbent who possesses the following: **Required Qualifications:** + US FDA regulatory experience in related drug or device area; + Demonstrated ... Acts as a critical collaborative partner with the Global Regulatory Affairs organization to ensure FDA /US input...the Global Regulatory Affairs organization to ensure FDA /US input into product development; + Represents US … 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
- 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
- Actalent (Piscataway, NJ)
- …development of global regulatory strategies for a clinical laboratory. + Prepare regulatory submission documents for the FDA or other regulatory agencies ... Job Title: Quality Assurance and Regulatory Affairs SpecialistJob Description As a Quality Assurance...working knowledge of applicable regulations and standards (eg, ISO, FDA , CAP, CLIA, GMP, GCP, GLP, ICH, and other… more
- Merck (Rahway, NJ)
- …user fees, and freedom of information + Facilitating execution of direct interactions with FDA + Monitoring the regulatory landscape and the effect changes will ... Medicine, Clinical Sciences, Collaborative Development, Continuous Monitoring, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, FDA Regulations,… more
- IQVIA (Wayne, PA)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the enhanced… more
- Abbott (St. Paul, MN)
- …trial operations and product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory ... communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA... regulatory standards including those set by the FDA or other worldwide regulatory agencies to… more
- Abbott (Santa Clara, CA)
- …of global regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class III medical devices and ... Clara, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within **Abbott Ventures**… more
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