- 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
- 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
- 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
- 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)
- …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)
- …modeling of tumor size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global...methods. Experience in IND, NDA and other submissions to global regulatory agencies. Skills in experimental design,… 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
- 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
- Edgewell Personal Care (Allendale, NJ)
- …Edgewell's values and behaviors. **Accountabilities** + Responsible for leading Edgewell's Global Regulatory organization. + Demonstrate strong business acumen, ... Canadian Registration Processes and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance. + Proven ability to… more
- Citigroup (New York, NY)
- …management position within the Controllers Organization that will report up through the Global Head of Regulatory and Capital Reporting. The individual will ... support effective decision making in the remediation of critical gaps in regulatory reporting and bolster the team's ability to meet regulatory commitments to… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead ... Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… more
