- West Pharmaceutical Services (Exton, PA)
- …approvals for market release and file maintenance + Works with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams ... competency including Quality Systems **License and Certifications** + Regulatory Affairs Certifications (RAC)-RAPS RAC certification(s) preferred **Travel… more
- Lilly (Indianapolis, IN)
- …for the business. RLT also provides regulatory law advice to Global Regulatory Affairs , Manufacturing & Quality , Global Patient Safety, Clinical ... meetings and other external activities. + Provide legal support to the Global Regulatory Strategy Teams and Americas Regional Regulatory Team and related… more
- Astellas Pharma (Northbrook, IL)
- …with local and global stakeholders (eg, Product Development & Manufacturing, Regulatory Affairs , Quality Assurance, Business Partners). Responsible for ... global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global … more
- J&J Family of Companies (Titusville, NJ)
- …interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality ... for the preparation and approval of essential documents for global regulatory filings. The CL will manage...emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/device… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** Reporting to the SVP of Global Regulatory Affairs , Patient Safety and Quality , the VP of R&D ... recommendations and execution of the worldwide R&D and Medical Affairs quality strategy as an independent and...vision for inspection management and responses, working closely with global regulatory agencies + Responsible for continuous… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device...Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... of drug approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities, Global Quality , Technical Operations, Business ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA)...lead on global project teams (Pharmaceutical Development, Quality , Manufacturing, Global Regulatory Strategy).… more
- Insight Global (Irvine, CA)
- Job Description A large medical device company is looking for a Regulatory Affairs Coordinator to help with compliance activities. The responsibilities include ... are not limited to: RA Coordinator I 1) Prepares, dispatches and files routine Regulatory Affairs documentation 2) Collaborates with Regulatory Affairs … more
- Insight Global (Irvine, CA)
- …with Regulatory Affairs staff to prioritize and dispatch routine regulatory submissions and labeling creation. Collaborate with Global and Regional RA ... large medical device company is looking for a Sr. Regulatory Affairs Specialist to help with compliance...required for health authority submissions. Coordinate, compile, and supply regulatory documents to global teams (Latin America,… more