- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ or Cambridge, MA **About the job:** The Manager , Global ... biological entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Regulatory Affairs Project Manager ** **Position Summary** Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager **.** The ... Regulatory Affairs Project Manager is responsible for ensuring that the company aligns...Days.** **This is a remote position.** Catalent is a global , high-growth, public company and a leading partner for… more
- Vantage Specialty Chemicals (Fairfield, NJ)
- …it here. For more information visit: www.vantagegrp.com or LinkedIn/vantage **POSITION SUMMARY** Regulatory Affairs Senior Manager is responsible for leading ... Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs . The person will be responsible for personal care,… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects… more
- J&J Family of Companies (Raritan, NJ)
- … groups in the establishment and implementation of lean, harmonized processes across MedTech Global Regulatory Affairs which may be supported by applications ... leadership, key SMEs, and end users * Leading MedTech Global Regulatory Affairs in using...understanding of data processing and analysis workflows + Project manager certification + Experience with visualization software/tools such as… 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
- Henkel (Bridgewater, NJ)
- …a thorough knowledge of products, chemistries and processes. + Leads regional and global product safety and regulatory affairs projects to simplify, ... Madison Heights, MI, United States, Bridgewater, NJ, Adhesive Technologies **Product Safety & Regulatory Affairs Specialist** At Henkel, you can build on a… more
- Meta (New York, NY)
- …relationships and serve as a dependable point of contact for the Public Affairs Global Rapid Response team across policy, communications, marketing, creative, ... In this role, you will be responsible for executing global and domestic Public Affairs marketing campaigns...environments, we'd love to meet you. **Required Skills:** Public Affairs Marketing Manager Responsibilities: 1. Set clear… more
- J&J Family of Companies (Raritan, NJ)
- Manager , Regulatory Program Manager (RPM) -...Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as ... 2406194310W **Description** Johnson and Johnson is recruiting for a Regulatory Program Manager . This position can be...and lifecycle documents) is required. + Demonstrated understanding of Global Regulatory Affairs processes is… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Intelligence Group! **In this role, a typical day might include:** The Regulatory Intelligence Manager performs proactive global monitoring and surveillance ... Team members as applicable. Regulatory intelligence information monitored covers a global scope. The Regulatory Intelligence Manager will support… more
- TD Bank (New York, NY)
- …regulatory interactions across TD Bank, affiliates, and the US Holding Company. The Regulatory Relationship Manager I is the primary point of contact and ... in various agency meetings on behalf of RPM, and serves as primary Relationship Manager on assigned examinations or regulatory matters + Performs QC of all… more
- Englewood Lab, Inc (Totowa, NJ)
- Responsibilities: + Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. + With the assistance of Head of R&D (or ... the Head of Quality/ Regulatory . + Assist the Manager of Regulatory Affairs during...elements of ISO 13485:2003. + Maintain familiarity with changing global regulatory requirements. + Responsible for any… more
- American Express (New York, NY)
- …like they belong. Join Team Amex and let's lead the way together. The Global Government Affairs group within the General Counsel's Organization seeks a Director, ... from the USRR Continuous Monitoring teams that directly support regulatory engagements, as well as the Global ...system enhancements, as needed. * Serve as the product manager for the USRR Reporting website. Understand requirements from… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …design, implementation, and analysis of clinical studies to support global regulatory submissions, payer submissions and medical affairs + Works with ... and methodology. He or she must have experience with regulatory submissions both in the US and outside of...influence others within the clinical research and development and global medical + affairs organization + Excellent… more
- Pfizer (New York, NY)
- …Pfizer Digital, etc.) + Develop Global RWE Advocacy Platform in partnership with Global Corporate Affairs team + Partner with Global Patient Experience ... Design and execute Breast Cancer Awareness Month internal communications in partnership with Global Corporate Affairs + Own and manage BreastCancerVision.com, a … more
- Pfizer (New York, NY)
- …to demonstrate and enhance value generation for all assets. The Global Scientific Affairs COVID & Flu Senior Manager will play a key role in delivering ... **ROLE SUMMARY** The Global Scientific Affairs COVID & Flu...and other Vaccines-relevant experience is highly desired. + Understanding global regulatory guidance for appropriate use and… more
- J&J Family of Companies (Raritan, NJ)
- …company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Local Trial Manager (LTM) actively contributes ... for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries....(LTM) may also perform the role of Clinical Trial Manager (CTM)/ Global Trial Lead (GTL) for single… more
- Danaher Corporation (New York, NY)
- …market access teams, HEOR, government affairs , medical & scientific affairs , product management, marketing, commercial, regulatory and clinical affairs ... The Senior Manager , Market Access Strategy & Payer Value Marketing...care organizations. This position is part of the Government Affairs and Market Access Team and will be located… more