- 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
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing and?implementing… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is… more
- 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
- Organon & Co. (Jersey City, NJ)
- …collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations , regulatory affairs , chemistry, manufacturing and ... 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical and/or… 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 (Rahway, NJ)
- …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
- Sanofi Group (Morristown, NJ)
- …opportunities, transforming concepts into business-ready solutions that future-proof Sanofi's Global Regulatory Affairs (GRA). Reporting to the Head of ... for scale. This role is ideal for an experienced regulatory affairs professional who has expanded into...to ensure smooth handoffs across the innovation funnel. + Co -create with Innovation Leads, Capability Analysts, and Process Owners… 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
- Organon & Co. (Jersey City, NJ)
- …Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well as ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… 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
- Organon & Co. (Jersey City, NJ)
- …development programs with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, Manufacturing ... and Controls (CMC), medical affairs and business development. Non-Clinical Safety Assessment Representative is...for reviewing and authoring non-clinical and clinical modules for regulatory submissions, briefing books and other regulatory … 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Affairs , Market Sciences, Clinical Development, Legal, Ethics and Compliance, Regulatory , Market Access, Commercial, and Government Affairs & Policy to ... digital efforts, working to roll out trainings in partnership with the Public Affairs Strategy and Operations team **Qualifications:** + Bachelor's degree plus… more
- Sanofi Group (Morristown, NJ)
- …scientific exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch ... **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA /...treatment landscapes for pipeline assets or marketed products. + Co -create the IEGP strategy with Medical Evidence Generation Lead… more
