- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for ... reviewing the CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders to formulate regulatory … more
- Merck & Co. (Rahway, NJ)
- …within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions Archive Operations serves as the ... Job Description Associate Director , Regulatory Submissions...Management, Employee Training Programs, FDA Regulations, Life Science, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Policy Implementation, Regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team.- The ... regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the world by facilitating… more
- Insmed Incorporated (NJ)
- …in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of ... science, we're in. Are you?About the Role:The IT Business Partner for Medical Affairs and Innovation serves as a strategic liaison between Information Technology and… more
- Merck & Co. (Rahway, NJ)
- …Office (PMO); and Administrative Professionals. Position Description/Summary: The GPAM Associate Director , Value & Implementation Project Manager (VIPM), ... V&I efforts to progress the R&D pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive… more
- Insmed Incorporated (NJ)
- …submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC, Clinical, Quality) to facilitate document ... we're in. Are you?About the Role:We're looking for an Associate , Regulatory Operations on the Regulatory...for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… 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 ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will ... trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is… more
