- Sanofi Group (Morristown, NJ)
- …collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug ... SOPs, GCP, ICH guidelines and other regulations. + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for… more
- Insight Global (Basking Ridge, NJ)
- …(starting with Paa) and will scale across the platform. Collaborate with project teams, clinical operations, regulatory affairs , IT, and external vendors to ... degree preferred. 10+ years of experience in pharmaceutical R&D, clinical development and/or regulatory affairs , with good understanding of the systems,… more
- Integra LifeSciences (Plainsboro, NJ)
- …may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs . + Project Management aimed ... technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct… more
- J&J Family of Companies (Titusville, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical ... adverse events (pre and post-marketing) for relationship to treatment** **Assists Regulatory Affairs in determining requirements for any corrective actions… more
- J&J Family of Companies (Raritan, NJ)
- …is preferred. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical , Medical Information, Pharmacovigilance, etc.) ... with Global Regulatory Leads (GRLs) and other functional area partners ( clinical , safety, market access, commercial, medical affairs ) to ensure the global… more
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will be an internal expert on ... the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs , Advertising and Promotion is responsible for providing… more
- System One (Plainsboro, NJ)
- …vendor onboarding and access provisioning in Vault - Liaise with Safety Scientists, QA, Clinical , and Regulatory Affairs to ensure cohesive documentation and ... filing, oversight, and retrieval of safety trial documentation within the Veeva Vault Clinical (eTMF), Quality and RIMS - Conduct quality control reviews and ensure… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …you to broaden your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is primarily focused on maintaining continued market ... independently and as part of a team. The Staff Regulatory Affairs Specialist will work in BD...Must be able to maintain confidentiality in dealing with regulatory and clinical documentation + Must be… more
- System One (Florham Park, NJ)
- Job Title: AD or Director, Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be local ... in IND/NDA development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director) in developing and executing regulatory… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …grow and become your best self. Become a **maker of possible** with us. The Regulatory Affairs (RA) Director is responsible for the management and setting the ... work for multiple product families, RA projects, or a Regulatory Affairs Platform. + Provides regulatory...Advance degree preferred. + RAC certification. + Experience with Clinical Trial applications (US IDE). + Medical device experience… more
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