- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:We're looking for an Associate, Regulatory Operations on the Regulatory team to help us expand what's ... possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Operations , you'll be responsible for the publishing, management,… more
- Parexel (Columbia, SC)
- …5 years of biotech/pharma industry experience, including 2+ years in labeling/ regulatory operations with global responsibility. - Experience leading teams ... Join us as a **Global Labeling Operations Manager** , where you'll work alongside a...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… more
- Lundbeck (Deerfield, IL)
- … regulatory affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations , US Labeling and Advertising and Promotion, International ... Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location:...in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee… more
- Merck & Co. (Rahway, NJ)
- …Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory ... 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end ...Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on… more
- Lundbeck (Deerfield, IL)
- …degree + 2 years of experience in Biotech, Medical Device or Pharmaceutical regulatory operations , regulatory affairs, marketing operations , or ... Commercial Operations Specialist Requisition ID: 7195 Location: Deerfield, IL,...ordering systems, tracking, and reporting. Additionally, in partnership with Regulatory Affairs, Promotional Review Committees (PRC/MLR), and Marketing, this… more
- Eisai, Inc (Boston, MA)
- …vendor management, and technical oversight to support the objectives of Global Regulatory Operations . The Associate Director will collaborate with the Heads ... the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final… more
- BeOne Medicines (Emeryville, CA)
- …that strengthen representative patient enrollment. This role collaborates across Clinical Operations , Regulatory , Development, and corporate functions to embed ... and consistency over time. + Work actively and directly with the Clinical Operations , Regulatory , Clinical Development, and Human Resources to support their… more
- Insmed Incorporated (NJ)
- …will be vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs, Operations , and Commercial teams to ensure seamless program ... possible for patients with serious diseases. Reporting to the SVP, Technical Operations , you will lead all Chemistry, Manufacturing, and Controls (CMC) activities… more
- GRAIL (Durham, NC)
- …the organization including but not limited to all-Quality, Clinical Laboratory Operations , Technical Operations , Regulatory Affairs, Compliance, ... This position is a key individual contributor in the Quality Operations organization, responsible for executing, maintaining, supporting, and improving GRAIL's… more
- Banc of California (Santa Ana, CA)
- …and projects as assigned. **WHAT YOU'LL BRING** + Strong expertise in wire operations , regulatory requirements, and technical understanding of wire systems and ... groups, and more. TOGETHER WE WIN(R) **THE OPPORTUNITY** The VP, Wire Operations Manager is responsible for overseeing and administering the Wire Operations… more
- Usaa (Charlotte, NC)
- …reward through effective challenge. Liaises with Compliance and CLO on legal & regulatory considerations that impact business operations and product offerings in ... in lieu of degree. Minimum Experience: 10+ years of risk management, regulatory or operations experience in a functional area such as insurance, banking, or… more
- Eisai, Inc (Bethesda, OH)
- …responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling ... operations and actively contribute to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in… more
- Caris Life Sciences (Irving, TX)
- …abstracts, peer-reviewed manuscripts, and presentations. + Partner cross-functionally with Regulatory , Clinical Operations , Biostatistics, R&D, Product, Market ... medical leadership across clinical development, product innovation, evidence generation, regulatory strategy, and external scientific engagement. The ideal candidate… more
- Delek US Holdings (Dallas, TX)
- …and retirement + Ensures compliance with cybersecurity, data privacy, and regulatory standards + Collaborates with operations , engineering, and IT/OT ... Sr Manager, Operations Technology Integration Location: Dallas, TX, US, 75024...role ensures that technology solutions align with business objectives, regulatory requirements, and industry best practices, while driving innovation,… more
- ERCOT (Austin, TX)
- …procedures. Cross-functional Collaboration: + Partner with Market Design, Settlements, Grid Operations , and Regulatory teams to support market initiatives, rule ... our industry today and in the future. The Market Operations Analyst Lead serves as a subject matter expert...expert and technical team lead within ERCOT's CRR Market Operations group. This role provides advanced analysis, operational oversight,… more
- Merck & Co. (Durham, NC)
- …Optimization, Process Simulation, Product Formulation, Quality Assurance Processes, Quality Operations , Regulatory Submissions, Risk Assessments, Risk Control ... Job DescriptionOur Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range… more
- Organon & Co. (Plymouth Meeting, PA)
- …with cross-functional colleagues in preclinical science, data science, clinical operations , regulatory affairs, chemistry, manufacturing and control (CMC), ... 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical and/or… more
- Insmed Incorporated (NJ)
- …clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations , Regulatory , and Clinical Development, as well as with ... support to exploratory analyses, both internally and in response to regulatory agencies' ad-hoc requests Ensures quality of deliverables by consistently applying… more
- BeOne Medicines (San Mateo, CA)
- …Teams (CST) and provide a high service level to internal stakeholders (eg Clinical Operations , Regulatory , Quality, CMC). + Work with Clinical Operations to ... + Coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations , CRO) and CMOs. + Support IRT user acceptance testing, develop… more
- BeOne Medicines (San Mateo, CA)
- …Teams (CST) and provide a high service level to internal stakeholders (eg Clinical Operations , Regulatory , Quality, CMC). + Work with Clinical Operations to ... May coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations , CRO) and CMOs. + Support IRT user acceptance testing, develop… more
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