- JABIL CIRCUIT, INC (Hunt Valley, MD)
- …validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory requirements (FDA, EMA, ICH, ... processes, supporting product quality, patient safety, and regulatory compliance This position requires strategic leadership,... with cGMP, FDA, EMA (Annex 1), and other global regulatory requirements for validation and qualification.… more
- Stanley Black and Decker (Towson, MD)
- ** Global Product Regulatory Compliance Senior Program Manager - Towson, MD - Hybrid** **Come build your career.** It takes great people to achieve ... and stakeholders. + Lead process improvement and automation initiatives for Global Product Regulatory Compliance . + Conduct post-project reviews… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is...drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH,… more
- Lilly (Washington, DC)
- …EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/ compliance issues** + Works with ... and inspection support that is provided by the RCPMR ( Regulatory Compliance and Post Market Reporting) team....information for use in various periodic reviews or metrics. ** Global and US Product Shortage** + Coordinate… more
- Oracle (Washington, DC)
- …products with applicable compliance deadlines. **Responsibilities** The Lead Product Regulatory Strategist role involves leveraging expertise in current ... informed decisions, streamline processes, and drive better health outcomes. As Lead Product Regulatory Strategist, you will be responsible for analyzing… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …(CGMP) regulations, Otsuka Quality Standards and US/ global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP ... **Job Summary** The Manager, Global Product Quality - Controlled Substances...& Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing,… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ... The Senior Manager, Global Product Quality - Biologics is...Suppliers to ensure compliance with local and global requirements as well as applicable regulatory … more
- Oracle (Washington, DC)
- …partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product ... Health Canada, and other global submissions) across global market ensuring compliance with regulatory...preferred. + Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance , Product … more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for directing clinical and commercial product quality to ... **Job Summary** The Associate Director, Global Product Quality - Biologics is...in a controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role… more
- Grant Thornton (Arlington, VA)
- We are seeking an experienced and strategic leader to serve as the Head of Global Product - Tax. This new role will drive the execution of Grant Thornton's ... enhance our professional tax services globally. The Head of Global Product - Tax will lead distributed...leaders, Technology leaders, and key corporate stakeholders (Risk, Legal, Compliance , Finance, HR, Operations) to ensure product … more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- **Job Summary** The Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight of clinical ... regulatory expectations and applicable cGMP/GDP quality standards. This role has global responsibility for directing clinical and commercial product quality… more
- Philips (Washington, DC)
- …aspects of product development and marketing plans, ensuring alignment with global regulatory requirements, offering strategic input during product ... to ensure proactive adaptation to regulatory changes and minimizing compliance risks. + Develops & facilitates comprehensive product compliance… more
- Sumitomo Pharma (Washington, DC)
- … activities for assigned project(s) in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC ... works closely with Regulatory Operations in the electronic submission + Ensure compliance with global regulatory requirements and adherence to … more
- Parexel (Washington, DC)
- … global markets? Parexel is seeking an experienced and highly motivated ** Global Regulatory Labeling Lead** to provide strategic leadership and operational ... Align labeling content and strategy across US, EU, and global regulatory teams; facilitate timely endorsement of...for correct submissions. + Ensure FDA Section 508 accessibility compliance on US labels. ** Global Implementation &… more
- Sumitomo Pharma (Washington, DC)
- …must be experience with supporting all aspects of global commercial product . The role will hold accountability for regulatory submissions, applicable ... management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international...of the scientific Medical Review Committee (sMRC) to ensure regulatory compliance for medical based communications, congresses,… more
- Gilead Sciences, Inc. (Washington, DC)
- …agency interactions, inspections, and regulatory responses. Ensure readiness and compliance for global commercialization. . **Design Control & Technical ... together. **Job Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with… more
- Parexel (Washington, DC)
- …for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional ... on impactful global programs that directly support patient safety and regulatory compliance . * Collaborate with a diverse, international team across multiple… more
- TechInsights (Washington, DC)
- …for maintaining product health, driving user engagement, and ensuring that Compliance Monitor evolves in step with global export control policies. WHAT ... range: $146,540 USD to $163,780 USD THE OPPORTUNITY The Compliance Monitors Technical Product Manager owns the...Define and maintain product roadmap aligned with compliance objectives + Translate regulatory changes into… more
- Oracle (Washington, DC)
- …applicable standards and regulations. + Collaborate with product development, regulatory , and quality assurance teams to ensure compliance requirements and ... strong partnerships with the business to identify and ensure compliance with regulatory requirements. You will work...with Oracle's product engineering teams to assess product functionality and develop regulatory strategy. +… more
- GRAIL (Washington, DC)
- …labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on international ... with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material… more
