- Formation Bio (New York, NY)
- … release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at ... Oversee and perform batch record reviews to ensure accuracy, completeness, and compliance with regulatory requirements. Manage QA release of clinical trial… more
- Formation Bio (New York, NY)
- …implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA, EMA), industry standards ... high-quality pharmaceutical products. Lead internal and external audits to assess compliance with regulatory requirements, identify areas for improvement, and… more
- Merck & Co. (Rahway, NJ)
- …identifying, assessing, and mitigating potential risks to ensure patient safety and product quality.Ensure compliance with all regulatory requirements and ... transfer portfolio for medical devices and combination products, as well as combination product stewardship for inline products. The Executive Director will lead… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director for Cell Based Sciences within Analytical R&D is responsible for providing strategic leadership and partnering with the ... from pre-clinical through clinical development and into commercial supply.The Executive Director reports to the Vice President, Analytical Research & Development and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn this Principal Scientist/ Director position within Translational Oncology, this team member will provide leadership for aligned and integrated ... projects when applicable, and execution of those strategies in collaboration with Product Development Teams (PDTs), Asset Development Teams (ADTs) and our diagnostic… more
- Merck & Co. (Rahway, NJ)
- … development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and ... verification testing strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance ... our pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs Liaison...functions with a high degree of independence and provides regulatory oversight for assigned products, to optimize product… more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, a Senior Principal Scientist/Senior Director , has primary responsibility for developing value evidence strategies, and ... in their HTA submissions. Incumbent is also expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development Team ... years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval… more
- Merck & Co. (Rahway, NJ)
- …ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical ... balancing needs of patients & ensuring stable supply of product . - Primary activities include, but are not limited...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules ... incumbent will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications skills,… more
- Merck & Co. (Rahway, NJ)
- …and applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... stability assays for testing of clinical trial material and in support of product and process development.A strong team player with excellent oral and written… more
- Ross Stores, Inc. (New York, NY)
- …learning opportunities and development for our teams\. **GENERAL PURPOSE:** The Director , Product Compliance & Regulatory Attorney will work as a member ... stakeholders on a broad range of topics and projects in the areas of product compliance , regulatory compliance , product safety, environmental, and… more
- Wabtec Corporation (New York, NY)
- …attorneys in the Legal Department. Areas covered include: ESG disclosure and reporting, product regulatory , stewardship and chemical compliance matters, and ... **How will you make a difference?** The ESG & Product Regulatory Legal Counsel position provides day-to-day...position serves as a subject matter expert in sustainability, product compliance , and EHS working closely with… more
- S&P Global (New York, NY)
- …Team:** This commercial position is part of S&P Global Market Intelligence's Regulatory Compliance Division. Reporting to the Commercial Head of Documentation ... that span client reference data collection and management, client lifecycle management, regulatory compliance , and document management. + ** Regulatory … more
- Citigroup (New York, NY)
- Serves as a senior function/business/ product compliance risk officer for Independent Compliance Risk Management (ICRM) responsible for establishing internal ... and related laws and regulations; Advanced degree a plus **Job Family Group:** Compliance **Job Family:** Product Compliance Risk Management **Time Type:**… more
- JPMorgan Chase (Jersey City, NJ)
- …offering a unique opportunity to shape the firm's tech risk strategy and enhance industry compliance . As a Tech Risk & Controls Director in the Cybersecurity and ... stakeholders, including key cross-functional team leads, regulators, and auditors, to ensure compliance with legal, regulatory , and industry standards + Manage… more
