- Haleon (Warren, NJ)
- …+ Enables the identification of emerging regulatory trends and evolving FDA expectations ** Regulatory Affairs Co -Op** The objective of the Regulatory ... see and manage their everyday health. That's an incredible opportunity . An exciting challenge. And a huge responsibility. We're...wide format used for submissions to the FDA. The Regulatory Affairs Co -Op will be… more
- Merck (Rahway, NJ)
- …process, knowledge of clinical regulatory documents, and hands‑on experience in regulatory affairs . The student should have strong interest in cancer ... independently and will also be expected to proactively collaborate with colleagues. The Regulatory Affairs department works in all of our therapeutic areas,… more
- Merck (Rahway, NJ)
- …chance to see if we are the right company for your long-term goals Global Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing CMC ... **Job Description** The Future Talent Program features Cooperative ( Co -op) education that lasts up to 6 months...organize LoQs + Analyze and trend; develop metrics + Regulatory Affairs Detailed Application Verification (DAV)- verification,… more
- J&J Family of Companies (Raritan, NJ)
- Regulatory Affairs Summer Intern - 2406211564W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation ... world for the health of everyone in it. Global Regulatory Affairs (GRA) is looking for a...Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for… more
- Merck (Rahway, NJ)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... health authorities, as needed, to mutually align on co -development needs and expectations for major project tasks such...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... assessing regulatory risk, and developing global filing strategies. + Co -lead marketing application submission teams for indications that are at regulatory… more
- Merck (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... SMEs, including leading cross-functional teams, to drive process improvements, streamline operations , and achieve business objectives on a global scale. + Deep… more
- Merck (Rahway, NJ)
- …for the Business Continuity Standards and Training (BCST) group within the Global Regulatory Affairs Clinical Safety (GRACS) Operations , Process & Systems ... Job Description The Future Talent Program features Cooperative ( Co -op) education that lasts up to 6 months...Final External Policy is the official approved version of regulatory requirements or expectations that have undergone a thorough… more
- The Mount Sinai Health System (New York, NY)
- **JOB DESCRIPTION** The Quality and Regulatory Specialist facilitates and participates in the implementation of the multidisciplinary hospital and system wide ... who coordinates the planning, monitoring and evaluation of the Quality and Regulatory Readiness program. Participates in planned and unplanned regulatory visit… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co -founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio ... therapy. This position is responsible for overseeing US promotional review operations , including routing all promotional material through a review/approval process,… more
- AbbVie (Florham Park, NJ)
- …scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs , market access, and commercial teams. + Ensure ... as an influential leader within the R&D organization to co -steward assets on cross-functional teams for assigned asset(s). The...compliance with regulatory and ethical standards in all medical … more
- J&J Family of Companies (Raritan, NJ)
- …limit to the impact you can make here. Are you ready to reimagine healthcare? Regulatory affairs (RA) is a profession developed from the desire of governments to ... The MedTech Global RA CoOp role will provide an opportunity to develop practical experience in one or multiple...strategic discussions to hone team collaboration skillset. + Learn regulatory affairs competencies to ensure product registration… more
- The Mount Sinai Health System (New York, NY)
- …faculty. InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event adjudication and Data Safety ... in federal and industry funding. This position is responsible for translating regulatory knowledge relating to human research, including federal, state, local and… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations , Medical Information,… more
- City of New York (New York, NY)
- …Medical Affairs , such as case management of patients with drug-resistant TB, regulatory affairs and the evaluation of newly arrived immigrants and refugees ... clinical data from surveillance registries and electronic medical records 3) Assist the Regulatory Affairs Unit in drafting Commissioner's Order on patients who… more
- Merck (Rahway, NJ)
- …used for support in the registration of animal health products + Collaborate with regulatory affairs to ensure, if required, regulatory authorities are aware ... support to the Clinical Study Team working with Clinical Operations Managers to plan and coordinate the monitoring and...and procedures + Communicate with all stakeholders (project manager, regulatory affairs , quality assurance etc.) and keeps… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements. + Supports Regulatory Affairs in providing quality content and review of documents ... key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,)...Committee. b. Quality leadership team c. Develop/ chair or co -lead quality council as necessary. + Ensure the vision… more
- The Mount Sinai Health System (New York, NY)
- …administrative, operational, and programmatic intricacies within the Cancer Institute among regulatory affairs , research finance, clinical operations , ... standards. Works closely with Tisch Cancer Institute offices (ie Quality assurance, regulatory affairs , disease specific clinical trial managers). + In… more
- Merck (Rahway, NJ)
- …Our team plays a critical role in managing the systems that support the Regulatory Affairs group, enabling the seamless integration and labeling of products to ... of the systems we manage. This internship provides an opportunity to gain practical experience in the integration of...capabilities to ensure they meet the needs of the Regulatory Affairs group. + Collaborate with IT… more
- The Mount Sinai Health System (New York, NY)
- …. The Regulatory Project Coordinator will be responsible for supporting the regulatory affairs team in managing and coordinating regulatory projects. ... the electronic Trial Master File (eTMF) and ensuring compliance with regulatory requirements. The coordinator will work closely with cross-functional teams to… more