- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(June through August) Preferred Skills: Interest in regulatory labeling operations and process optimization. Experience with project coordination or ... around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time… more
- RGP (Portland, OR)
- …Strong understanding of financiais systems, regulatory compliance , and business operations . + Proficiency in project management tools such as MS ... as SAP, Oracle, or NetSuite. + Strong familiarity with financial reporting standards and regulatory compliance frameworks. + Ability to thrive in a hybrid work… more
- BeOne Medicines (San Mateo, CA)
- … Regulatory Compliance and is responsible for driving program-level compliance initiatives, monitoring regulatory operations , and ensuring alignment ... This role provides compliance oversight and guidance across Regulatory Operations , Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical,… more
- SMBC (New York, NY)
- …discipline to follow up on issues until resolved. + Must be well organized with project management skills. + Regulatory compliance experience at a broker ... the First and Second Lines of Defense regarding a broad range of compliance and regulatory issues and works hand-in-hand with business/function partners to… more
- BeOne Medicines (San Mateo, CA)
- …Excellence plays a pivotal role for driving the successful execution of Global Regulatory Operations Strategy & Innovation programs and projects in a dynamic ... required. + 7+ years in the pharmaceutical/bio-pharmaceutical industry with prior Regulatory Operations related experience preferred. **Computer Skills:** High… more
- ValSource, Inc. (Rahway, NJ)
- …and ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead ... Verifications and system walkdowns to confirm systems meet design and client specifications. Regulatory Compliance : Ensure compliance with all relevant … more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director, Digital Clinical Operations - Project Lead, is responsible for coordinating and managing digital initiatives ... Clinical Operations (GCO) to enhance the effectiveness, efficiency, and compliance of operational systems and processes. This role ensures that digital projects… more
- Syner-G BioPharma Group (Boston, MA)
- …expertise to streamline operations , enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and deliver ... automation systems.Maritime facilities background (preferred).Familiarity with GMP environments and regulatory compliance (preferred).LEED certification, PE license, or… more
- Parexel (Trenton, NJ)
- …marketing pieces, and with Commercial for website postings if needed. + Work with Regulatory Operations , Regulatory Affairs, Tech Ops, etc. for labeling ... go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs, Technical Operations , Safety, and Commercial. You'll help… more
- Formation Bio (New York, NY)
- …nursing, pharmacy, or a related field. Minimum of 10 years of clinical project management/clinical operations experience, including at least 5 years in a ... to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the… more
- Ralliant (Raleigh, NC)
- …Draft, review, and advise on legal documents, policies, and communications related to regulatory compliance and public policy. + Monitor and interpret evolving ... good standing + 6-8 years of legal experience with deep expertise in international regulatory compliance . + Strong background in a highly regulated industry (eg,… more
- Teleflex (Morrisville, NC)
- Senior Regulatory Affairs Specialist **Date:** Nov 3, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** ... that make a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments… more
- CSL Behring (King Of Prussia, PA)
- …to internal stakeholders (eg, GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for ... applicable regulatory systems (eg, Veeva) to ensure tracking and compliance deliverables. + Applies the CSL Leadership Capabilities - Build Bridges, Think… more
- Entrust (Shakopee, MN)
- …Environment, or related field + Strong writing and communication skills + Project management or experience building and developing regulatory oversight programs ... help us anticipate the future.? We're looking for a ** Regulatory Specialist** - Hybrid in Shakopee, MN As a...you will make an impact:** + Work closely with Compliance , Procurement, Engineering, and product development teams to create… more
- Battelle Memorial Institute (Columbus, OH)
- …to mitigate risk. + Reviews project planning documents (technical protocols, project plans, test plans, etc.) for compliance with stated requirements (RFPs, ... + Audits documents, records, and work being performed to determine compliance to complex and nuanced requirements utilizing knowledge of assay-specific… more
- Parexel (Raleigh, NC)
- …guidelines + Partner with Subject Matter Experts to enhance quality, efficiency, and project management methodologies + Quality & Compliance Leadership + Ensure ... trends in patient safety + Apply in-depth knowledge of pharmacovigilance systems and regulatory requirements + Maintain compliance with ICH, GCP, and relevant… more
- Merck & Co. (Rahway, NJ)
- …IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory Operations , Regulatory ... Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with… more
- Merck & Co. (Rahway, NJ)
- … regulatory agency officials, conducting inspections of facilities or operations in supported areas, including GMP Certification inspection. Education Minimum ... Job DescriptionThe Rahway based Senior Specialist, Global Development Quality Operations , is responsible for independent approval of documentation to support GMP… more
- DESC (Seattle, WA)
- …medical, nursing, and case management services into cohesive and effective daily operations . Together with the Clinical Project Manager, this role forms ... reviews, psychiatric consultations, and multidisciplinary case conferences. **Quality Assurance & Compliance ** + Monitor adherence to all contract, regulatory ,… more
- Hawaiian Electric (Honolulu, HI)
- …matrix and other work management system interfaces. + Company, Regulatory , and External Approvals:Develops and prepares project -related information, ... preparing and providing testimony and presentations at public meetings and regulatory hearings as necessary. + Project /Program Controlling:Develops, automates,… more
