- 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 ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact… more
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... on the cutting edge of data readouts (consistent with FDA-approved labeling ), medical congress meeting outputs and podium & symposia presentations.Identify best… more
- Amgen (Washington, DC)
- …your best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Labeling Strategist, Manager ** **Live** **What you will ... Strategy Therapeutic Area Head for Inflammation and Rare Disease, the Regulatory Labeling Strategist is responsible for driving labeling strategy,… more
- Medtronic (Irvine, CA)
- …of medical device experience, including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling , or an advanced ... to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. + Facilitate review meetings online...+ Support the preparation of US and International promotional labeling material, including the creation of a claims matrix… more
- J&J Family of Companies (Raritan, NJ)
- …as a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager , Global Labeling Product Leader. This position is a hybrid role and ... in Raritan, NJ; Titusville, NJ; or Horsham, PA. The Manager , Global Labeling Product Leader will be...is required. + A minimum of 3 years of Regulatory Affairs experience in product labeling / labeling… more
- Pfizer (Groton, CT)
- The **Senior Manager , Global Labeling Lead (GLL)** has overall accountability for the development and execution of global labeling strategy for their ... Labeling Team and collaborate with stakeholders including Clinical, Medical, Safety, Regulatory , and Commercial + Drive global labeling strategy through… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …Variable (On-Demand) software with ERP/WMS systems (eg, SAP, Oracle, etc.). + Ensure regulatory compliance with labeling standards such as GS1, FDA, and UDI. ... year(s). + Implement and configure Variable (On-Demand) software for efficient labeling processes. + Automate labeling workflows using Variable (On-Demand)… more
- Abbott (Plymouth, MN)
- …device and management solutions for the treatment of structural heart disease. The ** Labeling Project Manager ** will be responsible for meeting business needs by ... Experience working in medical device industry with focuses on regulatory compliance, quality systems, labeling , or UDI...with focuses on regulatory compliance, quality systems, labeling , or UDI preferred. + Experience working with ERP… more
- Olympus Corporation of the Americas (Westborough, MA)
- … labeling -related matters. + Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling materials. + Responsible ... about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in ... global development projects and provide regulatory strategy for assigned projects that leads to a...project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions… more
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs, Advertising and Promotion will be an internal expert ... promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs, Advertising and Promotion is... impact of new campaign concepts, target, or product labeling , and to provide strategic regulatory guidance… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) ... The Senior Manager position within the Regulatory Affairs...to health authorities + Provide input to management during labeling development and negotiation to reflect commercialization objectives and… more
- Rise Baking Company (York, PA)
- …compliance guides, inspection reports, journals, meetings, etc. + Assist the Senior Regulatory Compliance Manager with sustainability customer requests such as ... palm oil and cocoa surveys + Assist Senior Regulatory Compliance Manager with sustainability directives involving regulatory initiatives + Support food… more
- Abbott (Sylmar, CA)
- …device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management team in ... CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine...appropriate); + Medical writing + Advertising and promotion + Labeling + Restricted substances reporting as required(eg REACH) +… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. **US Regulatory Affairs Lead -Senior Manager ** **Live** **What you will do** Let's do ... the Global Regulatory Team (GRT), they will achieve the desired labeling by developing and implementing regional regulatory strategies and managing effective… more
- Gilead Sciences, Inc. (Foster City, CA)
- …on new promotional concepts and campaigns. You may represent RA Ad/Promo in Regulatory Project Teams. You may also attend labeling meetings. **EXAMPLE ... Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core... Project Team meetings as needed. + May attend labeling meetings as needed, with managerial oversight. + Seeks… more
- Hologic (Marlborough, MA)
- Manager , Global Regulatory Affairs Marlborough, MA, United States The Manager , Global Regulatory Affairs will support leadership, ensuring alignment, ... consistency, and excellence in regulatory practices. This role will execute in the development...and Product Development on key initiatives. + Support global labeling initiatives including systems, processes and procedures to streamline… more
- Stryker (Shirley, MA)
- We are currently seeking a ** Manager , Regulatory Affairs** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). Ideally, this ... or Weston, FL with some workplace flexibility. As the ** Manager , Regulatory Affairs** , you will lead...with internal teams + Ensure quality and compliance of regulatory submissions, labeling , and marketing materials +… more
