- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA Competencies: Advanced… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and changes to key stakeholders Stewards NovoCare.com work through the Promotional Review Process in collaboration with agency partners and Promotional Review ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory , and clinical processes Ensures timely execution and follow-up, meets… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... a high performing statistics group to support translational medicine projects as a manager of at least 5 statisticians.Serve as a reviewer for the cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… more
- Novo Nordisk Inc. (Boulder, CO)
- …and lead process improvements. Relationships This position will report to the Senior Manager , Materials Management. Essential Functions Primary point of contact ... Novo Nordisk against Custom's fines and penalties. This role ensures regulatory requirements are adhered to and proper documentation, including transit documents… more
- Novo Nordisk Inc. (Durham, NC)
- …addressed & handled in close collaboration with production. Main duties include review of batch reports & release of incoming materials, deviations, change controls, ... review & approval of SOPs, QA presence & process...floor & improvement of Quality processes. Relationships Reports to Manager , QA. Essential Functions Ensure plant systems batch release… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Eisai, Inc (Exton, PA)
- …to Eisai management that the controls they have implemented are being executed.The Senior Manager is responsible for providing guidance on GxP and validation ... times and documentation overhead while maintaining the intended level of controls. The Senior Manager is responsible for supporting quality awareness efforts to… more
- Merck & Co. (Rahway, NJ)
- …supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders.--Works directly in ... within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities… more
- Novo Nordisk Inc. (Boulder, CO)
- …overall operation. Relationships The Technical Team Lead, API Manufacturing reports to the Senior Manager , API Manufacturing. The Technical Team Lead works with ... The Technical Team Lead, API Manufacturing acts as a delegate for the Senior Manager API Manufacturing. Essential Functions Responsible for the manufacture of… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance:-Achieve compliance goals through… more
- Grant Thornton (Charlotte, NC)
- As a Regulatory & Practice Review Seasonal Senior Manager you'll support audit teams for regulatory inspection with all with the resources, ... day-to-day may include: + Supporting audit teams that are selected for regulatory inspection + Communicating and interaction with the firm's regulators + Conducting… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... for patients suffering from immunological diseases. Position Summary: The Senior Manager , Clinical Regulatory will...optimal implementation of changes * Establish and implement internal regulatory processes, author and review SOPs and… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …other competencies necessary to ensure engaged and productive work environments. _The Senior Manager , International Regulatory Intelligence has the following ... reasonable accommodation to individuals with disabilities. **Brief Job Overview** The Senior International Regulatory Intelligence Manager will lead… more
- AbbVie (San Francisco, CA)
- …Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy, US & ... driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director,...members. + Key contributor responsible for the preparation and review of regulatory submissions consistent within US… more
- Huntington National Bank (Columbus, OH)
- Description Our Regulatory Reporting Accounting Senior Manager position is a highly visible and impactful financial reporting position working on ... loans. The primary responsibility will be to prepare, complete, review and submit required regulatory filings in compliance with the standards and guidance from… more
- Citigroup (Tampa, FL)
- …+ Analyzing and scoping the impact of new and complex regulatory developments across senior function/business/product, including cross-border impact. + ... navigate a complex organization; to influence and lead people across cultures at a senior level. + Experience in managing regulatory exams and relationships with… more
- USAA (Charlotte, NC)
- …**The Opportunity** As a dedicated InfoSec Regulatory Exam and Audit Oversight Manager Senior , you will manage one or more analytical, business or technical ... execution of one or more critical security domains or capabilities. + Executes senior leadership's strategic vision and leads their team in the compliant day-to-day… more
- Citigroup (New York, NY)
- …product breadth). The Treasury and Trade Solutions (TTS) Domestic Payments & Express Controls, Regulatory Management Senior Manager is a senior ... make sure a robust framework exists to manage and mitigate operational, compliance and regulatory risks across the business to enable the business to grow in a safe… more
