- 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
- Vontier (Annapolis, MD)
- …or managing enterprise product portfolios. * Familiarity with global product launches and regulatory / compliance considerations. * Fluency in English; ... **Job Overview** The Product Commercialization Manager is responsible for driving the...global standard work and aligning with Sales and Product teams. * Take ownership of the market model,… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …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
- Oracle (Annapolis, MD)
- …to develop product strategies and services that: + Support complex ** regulatory compliance ** and reporting workflows at scale. + Map to **clinical ... + **Shape global regulatory content development** : Translate regulatory and policy requirements into scalable, AI-ready product capabilities. +… more
- Oracle (Annapolis, MD)
- …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. (Annapolis, MD)
- The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the ... product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …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
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …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
- Oracle (Annapolis, MD)
- …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
- Sumitomo Pharma (Annapolis, MD)
- … 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
- Sumitomo Pharma (Annapolis, MD)
- …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
- Parexel (Annapolis, MD)
- …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
- Oracle (Annapolis, MD)
- …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 (Annapolis, MD)
- …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
- Oracle (Annapolis, MD)
- …This is a **high-impact** role that directly enables Oracle Health to meet regulatory requirements, maintain compliance across global markets, and support ... accurately captured. **Cross-Functional Partnering** + Partner with engineering, applied science, product , and regulatory leaders to gather technical inputs. +… more
- Oracle (Annapolis, MD)
- …stakeholder communication for smooth and timely rollouts. + **Support Global Compliance & Certification:** Collaborate with legal, regulatory , and product ... Help lead the efforts across both HDI global engineering and product teams regarding healthcare compliance and documentation requirements for HDI … more
- Parexel (Annapolis, MD)
- We are seeking a motivated **Senior / Regulatory Affairs Consultant - Advertising & Promotion** to join Parexel and work as a trusted partner within a major client ... that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You'll play a key role in supporting product … more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …readiness activities related to all global labeling components. + Represent Global Labeling on product -specific Regulatory and Cross-Functional teams, as ... alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all...to ensure that all labeling is aligned with the product global strategy and key messaging. +… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and ... data management, and medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …and operational efficiency. + GMP Compliance : Ensure all quality processes meet global regulatory requirements (eg, FDA, EMA, PMDA) and align with current ... The Director, Global Product Quality, GMP Processes is...leadership role. + Deep understanding of GMP regulations and global regulatory requirements (eg, 21 CFR Parts… more