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Regulatory Affairs Jobs in Trenton

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Search Results - Regulatory Affairs Jobs in Trenton
Daiichi Sankyo, Inc.-Trenton
pharmaceutical experience including 5 years of experience within Regulatory Affairs  •  Knowledge of IND, NDA/BLA submission experience  •  Experience with regulatory submission strategy globally will be preferred but not required.  •  Experience in providing...
Biogensys-Trenton
We are hiring an Administrative Assistant IV for one of our clients in Hamilton, NJ. Job Description:  •  The Office of Legal and Regulatory Affairs and Beneficiary Administrative Action unit needs temporary clerical staff to assist in processing...
jobvertise.com -
Daiichi Sankyo, Inc.-Trenton
discipline required  •  Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred Experience Qualifications  •  4 or More Years in the pharmaceutical industry preferred  •  1 or More Years in regulatory affairs required  •  Experience in (s)NDA/BLA filing...
Trenton
and Regulatory Affairs in the preparation of project-related documents and regulatory submissions, including Investigator’s Brochures, Annual Reports, INDs and NDAs.  •  Participate in investigator meetings, capturing VOC and translating company needs/strategy...
pacira.com -
Daiichi Sankyo, Inc.-Trenton
between the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist...
Trenton
Sales, Professional Education, Regulatory Affairs, and Legal; and with external consultants. Qualifications: Qualifications:  •  Proven ability to think strategically and succeed with indirect influence and independent direction  •  Current and relevant...
pacira.com -
Daiichi Sankyo, Inc.-Trenton
focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. We are currently seeking a Regulatory Affairs Intern for summer 2025. This full-time position works for approximately...
Daiichi Sankyo, Inc.-Trenton
Ph.D., MD, JD) preferred. Experience Qualifications:  •  10 or More Years in the pharmaceutical industry required.  •  8 or More Years in regulatory affairs  •  Experience in providing regulatory strategic input into the drug development process...
Daiichi Sankyo, Inc.-Trenton
pharmaceutical industry experience required  •  4 or More Years of direct regulatory affairs experience, including US labeling experience required  •  Experience with ex-US labeling (outside the US) preferred Travel - Ability to travel up to 10% Daiichi Sankyo, Inc...
Daiichi Sankyo, Inc.-Trenton
focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team...
Daiichi Sankyo, Inc.-Trenton
centered around rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and operational...
Daiichi Sankyo, Inc.-Trenton
Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics...
Daiichi Sankyo, Inc.-Trenton
Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings with CROs, License Partners, and PV vendors. Provide PV oversight of the DSI Call Center. Provide oversight of ICSR processing activities including, Safety...
Daiichi Sankyo, Inc.-Trenton
focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Intern for summer 2025. This full time position works...
Daiichi Sankyo, Inc.-Trenton
and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection  •  Supports Regulatory affairs...

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