- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... rapport and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ colleagues regarding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry required.8 or More Years in regulatory affairsExperience in providing regulatory strategic input into the drug development process with thorough ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 37.5 hours per week. Responsibilities:Support Regulatory Affairs Chemistry, Manufacturing, and Controls team with Investigational New Drug … more
- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy globally will be preferred but not required.Experience in providing regulatory strategic input into the Oncology drug development preferred.Ability ... and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Genmab (Plainsboro, NJ)
- …US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross functional ... authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior Director, US Medical … more
- Insmed Incorporated (San Diego, CA)
- …CRS will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs , drug safety, and quality assurance ... scientific review of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator… more
- Tris Pharma (Monmouth Junction, NJ)
- …working knowledge of regulatory and industry standards related to Medical Affairs role including Food and Drug Administration (FDA), Office of Inspector ... small MSL team. Collaborating closely with, and reporting directly to, VP/Medical Affairs in developing medical strategic and tactical plans the incumbent supports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager, Regulatory Affairs Labeling position will provide Regulatory support ... for FDA- approved labeling including updates to Reference Listed Drug , USP updates and updates for new Regulatory...in Life Sciences preferredExperience Qualifications4 or More Years direct regulatory affairs experience.4 or More Years in… more
- Genmab (Plainsboro, NJ)
- …this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and ... in particular security architects and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM Genmab US, IT Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborations within and across line functions, eg Clinical Development, Medical Affairs , Regulatory Affairs , Clinical Operations. Formulates strategic ... with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge.This position independently addresses… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. - Specifically, The Executive Clinical Director… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be… more
- Merck & Co. (Rahway, NJ)
- …will manage, develop and maintain positive relationships within the Corporate Affairs team, closely partnering with our Company's Research Laboratories, Human ... biology and high-level scientific concepts and approaches, clinical research and drug discovery and development. Furthermore, this leader is dedicated to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …such as (but not limited to) Clinical Development, Global Medical Affairs , Biostatistics, Clinical Pharmacology, Regulatory , Marketing and Market Access. ... o Express an interest in Leadership and Global Research and Development Drug Processes. Prior experience in project management or project management software such… more
- Lilly (Indianapolis, IN)
- …field from an accredited college or university + At least 5 years of regulatory affairs experience with research-based drug development, including early ... (first in human, Ph1/Ph2) submission experience. + Demonstrated understanding of clinical drug development and regulatory affairs , including regulations in… more
- Takeda Pharmaceuticals (Lexington, MA)
- …PhD, MS, MBA, JD) preferred. + You have a minimum of 4 years' experience in drug , biologic or device Regulatory Affairs or related field, including a minimum ... potential issues. **POSITION ACCOUNTABILITIES:** + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations… more
