- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- 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
- 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
- Genmab (NJ)
- …quality, and scientific integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our ... science through compelling clinical and regulatory documents. You'll be at the heart of a...trial teams to manage timelines, facilitate meetings, and lead review cycles.Provide expert peer review and editing… more
- Merck & Co. (North Wales, PA)
- …scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… 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
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in ... the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and ... change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor… 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
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …guidance from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee ... The Senior Manager position within the Regulatory Affairs...A&P support is provided to stakeholders + Collaboration with Regulatory Therapeutic Area Leads to review key… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs, Advertising and Promotion will be an ... enforcement trends governing the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs, Advertising and Promotion is… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the ... Senior Manager of Regulatory Operations is responsible for...Coordinating and consulting with other departments on the content, review , and assembly of regulatory documentation. Ensure… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy US and ... 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
- Abbott (Alameda, CA)
- …the way people monitor their glucose levels with our new sensing technology. This ** Senior Regulatory Affairs Manager - APAC** position will work closely ... working mothers, female executives, and scientists. **The Opportunity** This S **enior Regulatory Affairs Manager - APAC** position will work on-site at… more
- J&J Family of Companies (Irvine, CA)
- …States {+ 22 more} **Job Description:** Johnson & Johnson is currently seeking a Senior Manager , Source Regulatory Compliance to join our Regulatory ... deliver on quality and compliance commitments. Develop proactive approaches to address regulatory trends. + Provide oversight and compliance review of Suppliers… more
- Charles Schwab (Austin, TX)
- …tracking of account-related communications to clients across many different business units. Our new Senior Manager will also be an integral part of our robust ... and safeguard the Schwab brand. The Client Service and Regulatory Communications team is part of the Central Marketing...role as a trusted partner. We're looking for a Senior Manager to: + Manage the development… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . The primary responsibility of a Senior Manager in Commercial Regulatory Affairs is to ... JD). + Candidate should have a minimum of 1-2 years Regulatory promotional review experience. + Candidate should have experience providing strategic direction to… more
- Comcast (Philadelphia, PA)
- …we want you to fast-forward your career at Comcast. **Job Summary** Responsible for review and analysis of regulatory reporting, including reports filed with the ... compliance and high-quality external reporting. **Job Description** **Core Responsibilities** + Review content and disclosures within various regulatory reports,… more
- NRG Energy, Inc. (TX)
- …Facebook, Instagram, LinkedIn and X. **Overview** : This position works with the Senior Director, Gulf Coast Environmental Business to support management of the Gulf ... compliance programs, focusing primarily on environmental data and reporting, regulatory compliance, obtaining project related permits, renewal of existing permits,… more
