- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret ... the impact of regulatory changes to the pharmaceutical environment. **Job Description** +...JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and… 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** Are ... intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post-marketing stages. The team creates… more
- Bristol Myers Squibb (Madison, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director Commercial Regulatory Affairs** **Description** : The role ... of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific...and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and… more
- Lilly (Indianapolis, IN)
- …and/or visas for this role. **Additional Skills/Preferences:** + Experience counseling on drug regulatory matters in Canada, Brazil and Mexico + Prior ... **Organization Overview:** This position will be part of the Regulatory Legal Team (RLT), which reports up through Lilly's...drug , medical device and diagnostic clinical programs and regulatory submissions in the US and other Americas Region… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA) teams by...accommodation will be considered. A post-offer background check and drug screen is required. Additional pre-employment requirements may be… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- GRAIL (Concord, NH)
- …For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III...and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performing… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals. **Job Description** The Assoc. Director, IT Regulatory , Clinical and Enterprise Systems is an integral part of bringing ... RayzeBio's innovative drug products to patients in need. In this role,...processes to achieve commercialization objectives across the Clinical Operations, Regulatory , Planning and Enterprise Systems. The role will ensure… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director, Drug Product Manufacturing Science & Technology, you will be ... Takeda's global subject matter expert for small-molecule drug product and packaging. You will lead how tablets,...drug product and packaging processes in line with regulatory and Takeda standards. + Act as part of… more