- 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
- Massachusetts Psychological Association (Wellesley, MA)
- …with weekly or monthly, as appropriate, updates on matters related to legislative affairs , regulatory issues, and health plan meetings *Clearly communicate MPA's ... Massachusetts Psychological Association (MPA) is seeking a Director of Professional Affairs . The purpose of the Massachusetts Psychological Association is to advance… 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
- 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
- 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. (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
- 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
- Kenai Therapeutics (San Diego, CA)
- …Cross-Functional Collaboration: Lead and collaborate with other functional areas, including Regulatory Affairs , Medical Affairs , Biometrics, and Research, ... clinical trials, with a focus on meeting project milestones, timelines, and regulatory requirements. The VP of Clinical Operations will collaborate closely 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
- 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
- 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
- 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
- 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
- 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
- AUROBINDO (Dayton, OH)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... operational problems and inefficiencies and recommend resolutions.Participate in any regulatory inspections from various organizations such as FDA, Environmental… more
Related Job Searches:
Associate Director Regulatory Affairs,
Director Global Regulatory Affairs,
Director Regulatory Affairs,
Manager Regulatory Affairs,
Principal Regulatory Affairs Specialist,
Regulatory Affairs Specialist,
Senior Director Regulatory Affairs,
Senior Manager Regulatory Affairs,
Senior Regulatory Affairs Specialist,
Sr Regulatory Affairs Specialist