- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to ... with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA strategic plans and the tracking… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs ) as well as DSI employees performing Global roles in the ... limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...United States (such as Global Marketing, Global Medical Affairs ). For these areas, acts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset,… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory ... biological entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we ... **The opportunity** Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager (Parsippany, NJ)...committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without… more
- System One (Florham Park, NJ)
- Senior Manager , Regulatory Affairs (BRANDED PRODUCTS) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Overview The ... Contractor - Senior Manager , Regulatory Affairs - Quality...meetings related to QOL initiatives. + Support coordination with global regulatory counterparts to ensure alignment of… more
- Haleon (Warren, NJ)
- …Care to join us. It isn't a question. **About the role** The **Senior Manager , US Regulatory Affairs -Wellness** is responsible for end-to-end regulatory ... for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol,...Science Biology, Chemistry) + 7+ years of experience with Regulatory Affairs + 5+ years working specifically… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of ... regulatory affairs related to the development of...+ Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs - Regulatory Project Management ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory… more
- Deloitte (New York, NY)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... a digitally enabled, equitable future of health As a Manager in our AI & Data team, you will...+ Veeva RIM and/or QMS implementation + Understanding of regulatory data and regulatory filing requirements +… more
- Deloitte (New York, NY)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... digitally enabled, equitable future of health As a Senior Manager in our AI & Data team are expected...+ Veeva RIM and/or QMS implementation + Understanding of regulatory data and regulatory filing requirements +… more
- Englewood Lab, Inc (Totowa, NJ)
- Reports to: Manager of Regulatory Affairs Responsibilities: + Assist the Manager of Regulatory Affairs during cGMP, Environmental, and ... the Head of Quality/ Regulatory . + Assist the Manager of Regulatory Affairs during...elements of ISO 13485:2003. + Maintain familiarity with changing global regulatory requirements. + Ability to work… more
- System One (Raritan, NJ)
- Title: Global Medical Affairs Project Manager Location: Must be local Raritan, NJ and required to go onsite 2 days a week onsite Type: Embedded Start Date: ... ASAP Leading Pharmaceutical Company located in NJ is hiring a Global Medical Affairs Project Manager 3+ years industry experience. If you want to be a part… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …preparation of challenging communications + Manage the preparation for interaction with global regulatory authorities (eg, meetings, IR responses, inspections) + ... RA in a timely manner + Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC/CP prduct development… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +… more
- Englewood Lab, Inc (Totowa, NJ)
- …(QMS) in compliance with US 21CFR 210, 211. + Maintain familiarity with changing global regulatory requirements. + Assist with CARES Act drug reporting, Product ... Responsibilities + Assist the Manager during cGMP, Environmental, and Regulatory audits. + Assist the Manager to create and collate product master files… more
- Bausch Health (Bridgewater, NJ)
- …the processes of booth activities + Works cross-functionally with other Medical Affairs , Regulatory , Pharmacovigilance matrix team members, as necessary + ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...drive our collective progress and impact. The Medical Information Manager will effectively communicate accurate, scientific, and balanced medical… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead in Global ... Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain...ensuring that corporate goals are met. With support from manager , acts as key internal leader and driver of… more
