- Parexel (Annapolis, MD)
- … 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
- 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
- Parexel (Annapolis, MD)
- …management experience is required. - Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. - Proven expertise ... industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical… 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
- 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
- Parexel (Annapolis, MD)
- …members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance . **About the Role** As a **Senior Physician in ... drug safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure… more
- Parexel (Annapolis, MD)
- …and payment issues etc.) + Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the ... + Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible with CRA for… more
- Parexel (Annapolis, MD)
- …and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key ... the quality of investigator sites (eg patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction,… more
- Organon & Co. (Annapolis, MD)
- …together and Keep moving. + Ensures proper diligence on policy, legal, regulatory , and company compliance issues. **Required Education, Experience and Skills** ... customer; negotiation and execution of pharmacy discount agreements and product contract offerings; individual account performance against strategic, financial and… 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. (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
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …(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
- 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)
- …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
- Grant Thornton (Baltimore, MD)
- 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. (Annapolis, MD)
- **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
- 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
