- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader ... RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of Regulatory … more
- Nura Bio (South San Francisco, CA)
- …across diseases of the central, peripheral, and ocular nervous system. The VP/Head of Regulatory Affairs will be a key member of our clinical leadership team, ... alignment with regulatory requirements. *Mentor and develop the regulatory affairs team, fostering a culture of continuous learning and professional growth.… more
- Merck & Co. (San Diego, CA)
- …regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.Provide final ... reportsInvestigator brochuresLocal registration study protocols for secondary marketsRepresent Global Regulatory Affairs on internal committees (eg, DRC,… more
- Merck & Co. (Rahway, NJ)
- …edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset ... Job DescriptionThe Global Senior Director of Medical Affairs (GDMA) for Melanoma coordinates the development of the Global Scientific and Medical Affairs Plans… more
- Merck & Co. (Rahway, NJ)
- …plans and benefits DD&T lab operations.Collaborate across DD&T sub-functions, regulatory affairs , quality assurance, Pharmaceutical Operations, Analytical R&D, ... efficient management of data across the organization, including compliance with regulatory standards, and the optimization of laboratory operations and workflows via… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs,… 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 ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (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
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Pulmonary Disease Research, Pulmonary Disease Treatment, Pulmonary Disorders, Pulmonology, Regulatory Affairs Compliance, Regulatory Compliance, Scientific… 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 ... Development, Ethical Standards, Intellectual Curiosity, Management Process, Medical Research, Regulatory Affairs Compliance, Regulatory Reporting,… more
- Aequor (South San Francisco, CA)
- …tracking, and audit readiness. You will work cross-functionally with content strategists, regulatory affairs , product owners, and engineering teams to ensure ... tagging strategy to power personalization, AI/ML classification, and dashboard reporting. Regulatory Support & Audit Readiness Ensure metadata compliance with … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
- Insmed Incorporated (San Diego, CA)
- …with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.ResponsibilitiesEDC System Design & ... CDISC ODM StandardsData Quality & Compliance:Ensure EDC systems comply with regulatory requirements (eg, FDA, EMA, ICH-GCP) and company SOPsPerform user acceptance… more
- Merck & Co. (Boston, MA)
- …as immunology, neurology, cardiometabolic and others as needed by the pipeline.Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate operational meetings with CROs, License Partners, ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs , including reviews/approvals of Change Control Reports ... required documentations and change control activities, in liaison with PD/QA/QC/ Regulatory AffairsDesigns experimental plans; Critically analyzes data and information… more
- Merck & Co. (Boston, MA)
- …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 May Be… more
