- Parexel (Trenton, NJ)
- …GCTO Country Operations , other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is fully informed and prepared to ... **_Parexel FSP has an exciting opportunity for a Clinical Quality Operations ...well as preparing for, management and follow up of regulatory inspections. **Primary Duties:** Operational Quality Management: + Develop… more
- Haleon (Warren, NJ)
- …and + identifying emerging regulatory trends and evolving FDA expectations. **The Regulatory Affairs Co -Op Associate** The objective of the Regulatory ... providing visibility to potential gaps. In this role, the Co -Op Associate will be provided with the opportunity...wide format used for submissions to the FDA. The Regulatory Affairs Co -Op will be… more
- Sumitomo Pharma (Trenton, NJ)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... new and established programs. This position reports to the Chief Medical Officer . **Job Duties and Responsibilities**...to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Affairs , Biopharma R&D. This position leads the Regulatory Affairs for biopharma R&D, report to the Chief Development Officer for ... Duties and Responsibilities** **_Regulatory Strategy_** + Develop and Manage Regulatory Affairs Strategy + Develop and gain... Regulatory matters in close partnership with the Chief Development Officer and other key stakeholders… more
- Merck (North Wales, PA)
- …responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. ... Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Regulatory Affairs … more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Sumitomo Pharma Co ., Ltd. is a global pharmaceutical company based...Regulatory Affairs (GRA) team based in the...prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission +… more
- Sumitomo Pharma (Trenton, NJ)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Sumitomo Pharma Co ., Ltd., is a global pharmaceutical company based...Global Regulatory Affairs (GRA) team based in the...prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission +… more
- J&J Family of Companies (Horsham, PA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs , Regulatory Affairs , Sales, Marketing, Legal, etc. is… more
- J&J Family of Companies (Raritan, NJ)
- …profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... optimization and next-generation submission transformation. A key member of the ** Regulatory Operations & Digital Innovation** ( **RODI) Senior Leadership… more
- J&J Family of Companies (Raritan, NJ)
- …closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, Clinical and ... of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related discipline. Advanced degree preferred. + A… more
- Pfizer (New York, NY)
- …You Will Achieve** You will represent Pfizer as an approval liaison in the regulatory affairs team assisting with diagnostics regulatory tasks. You will ... and accomplishments. + Liaise with and provide input/direction to Clinical Trial Regulatory Operations , Clinical Diagnostics, and other key stakeholder to ensure… more
- J&J Family of Companies (Raritan, NJ)
- …leadership via matrix interactions also includes individuals from project management, operations , regulatory affairs , data management, medical writing, ... Clinical and Indication Compound Development Teams . Colleagues from project management, operations , regulatory affairs , data management, medical writing,… more
- Danaher Corporation (New York, NY)
- …across Danaher by collaborating with cross-functional teams including Product Management, Legal, IP , Finance, R&D, Regulatory Affairs , Clinical Affairs ... to execute with supporting organizations (sales, commercial marketing, medical affairs , R&D, manufacturing, regulatory , quality, etc.) on...remote position. In this role, you will have the opportunity to: + Co -create franchise strategy in… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Bristol Myers Squibb (Princeton, NJ)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... personal lives. Read more: careers.bms.com/working-with-us . **Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:** The selected candidate will… more
- Merck (Upper Gwynedd, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5 more}… more
- JPMorgan Chase (New York, NY)
- …Drive firmwide global consistency in regulatory responses, working closely with Regulatory Affairs and Corporate Sustainability teams and other CNS Risk ... **Summary** The Business Implementation and Regulatory Strategy (Americas) will be responsible for the...more information about requesting an accommodation. JPMorgan Chase & Co . is an Equal Opportunity Employer, including… more
- Bristol Myers Squibb (Princeton, NJ)
- …implementation of clinical trials in collaboration with cross-functional teams (eg, Clinical Operations , Data Management, Regulatory Affairs ). + Conduct ... careers.bms.com/working-with-us . **Position Summary** The Associate Clinical Scientist/Clinical Science co -op function provides scientific expertise necessary to design and… more
- Sumitomo Pharma (Trenton, NJ)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... Sumitomo Pharma Co ., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo… more
- Merck (West Point, PA)
- …Actions (CAPAs). + Background in quality control, quality assurance, auditing or regulatory affairs . + Effectiveness and creativity in approaching and solving ... of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent… more