- Formation Bio (New York, NY)
- …clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a ... sites. Regulatory Compliance & Submissions Ensure all CMC activities comply with global regulatory expectations (eg, FDA, EMA, ICH); author and review … more
- Eisai, Inc (Nutley, NJ)
- …industry preferred.Skills:Eisai Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… more
- Merck & Co. (Rahway, NJ)
- …- Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various ... every aspect of our business processes, systems, and data.The Associate Director will collaborate and interact with cross-function teams to identify opportunities… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive innovation through… more
- Merck & Co. (Rahway, NJ)
- …within the networkOversee health authority reporting program to ensure compliance to global regulatory reporting requirements (eg, Field Alert Reports (FARs), ... Activities: Oversee the Compliance, Remediation, and Support (CRS) team within Global Quality Compliance Support. Provide compliance leadership and direction to our… more
- Merck & Co. (Rahway, NJ)
- …to ensure compliance and reduction in workplace Industrial Hygiene risks.Lead global continuous improvement initiatives to improve global Industrial Hygiene ... the globe.Identify, interpret and perform impact analysis on emerging global industrial hygiene regulations, guidelines and consensus standardsAudit Industrial… more
- Merck & Co. (Rahway, NJ)
- …with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics ... commercialization Provide technical oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs for… more
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Eisai, Inc (Nutley, NJ)
- …responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis ... responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis… more
- Merck & Co. (Rahway, NJ)
- …capabilities, and drive excellence in safety, compliance, supply, and productivity. Global Impact:Collaborate with colleagues across the US and internationally to ... storage. Your work will shape the future of biologics on a global scale.Key Responsibilities:Technical Strategy:-Deliver robust DS & cell bank process and analytical… more
- Merck & Co. (Rahway, NJ)
- …endpoints including proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in ... - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global...Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a ... Review process change requests and deviation reports while ensuring regulatory compliance. Education and Minimum Requirements:Bachelor's degree in engineering,… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The… more
- Merck & Co. (Rahway, NJ)
- …execution, reporting and interpretation of data. Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend ... Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As… more
- Merck & Co. (Rahway, NJ)
- …optimizing model-based analyses on programs. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics ... and verbal communication. Experience in IND, NDA and other submissions to global regulatory agencies. An exemplary record of increasing responsibility,… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Merck & Co. (Rahway, NJ)
- …DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and ... to produce safe, effective, innovative medicine.The Senior Principal Scientist/Senior Director is responsible for protocol development and medical/scientific oversight… more
- Merck & Co. (Rahway, NJ)
- …innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and ... oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will… more
- Lilly (Stamford, CT)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead ... (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the accountable… more
