- Formation Bio (New York, NY)
- …ensures that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial ... degree (eg, MSc, PhD, MBA) in a related field. Preferred: Experience with global clinical trials and regulatory submissions. Formation Bio is headquartered in… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution ... release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs,… more
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... Job DescriptionAssociate Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department… more
- Merck & Co. (Rahway, NJ)
- …day-to-day coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and ... 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)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our ... 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)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Specifically, the Director may ... Job DescriptionOur company is a global health care leader with a diversified portfolio...radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions.Lead the Device Development… 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)
- …products. Serve as outcomes research representative on cross-functional regional and global teams.Critically assess drivers and barriers to reimbursement and market ... access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In collaboration with internal teams and… more
- Merck & Co. (Rahway, NJ)
- …(Executive Director ) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing ... to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications...and in the field of Thoracic Oncology .The Executive Director , PDT Lead will manage the entire cycle of… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May ... Job DescriptionOur company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and… 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
- Merck & Co. (Rahway, NJ)
- …environment of mutual respect, diversity, encouragement and collaboration. As part of our global team, you will have the opportunity to collaborate with talented and ... Responsibilities include, but are not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of… 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
- Danaher Corporation (Port Washington, NY)
- …Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory ... ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products within Regeneron's Genetic Medicine ... Portfolio. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on… 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 ... enable remediation of critical gaps in regulatory reporting and bolster the team's ability... reporting and bolster the team's ability to meet regulatory commitments to various regulators (local regulators, US Federal… more
- S&P Global (New York, NY)
- …exchange of regulatory data and documentation. The team collaborates with global regulatory bodies, including ISDA, to support protocols for Dodd-Frank, ... **The Team:** This commercial position is part of S&P Global Market Intelligence's Regulatory Compliance Division. Reporting...is part of S&P Global Market Intelligence's Regulatory Compliance Division. Reporting to the Commercial Head of… more
- S&P Global (New York, NY)
- **About the Role:** **Grade Level (for internal use):** 14 **Impact:** Reporting to the Global Head of Ratings Strategy, the Senior Director of Strategy and ... teams of subject matter experts. + In close partnership with S&P Global Ratings Strategy and SPGI strategy and corporate development leaders, work on… more
- American Express (New York, NY)
- …analytics on #TeamAmex. American Express is seeking a skilled Regulatory Compliance Director to lead the global regulatory compliance function within the ... on maintaining a comprehensive and up-to-date legal inventory that aligns with global regulatory requirements and supports business objectives. + Design and… more
