- Kura Oncology (Boston, MA)
- …grit drive all behaviors, decisions, and actions. ESSENTIAL JOB FUNCTIONS: The Assoc Dir/ Director , Regulatory Affairs will be responsible for developing, ... implementing, and providing guidance on US and global regulatory strategies to support development of Kura's oncology and hematology portfolio. The individual… more
- Leica Biosystems (Boston, MA)
- …compliance, driving innovation and excellence in the Biopharma sector.This position reports to the Director , Regulatory Affairs and is part of the Global ... about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development… more
- Kura Oncology (Boston, MA)
- …a plus. Collaborates with the cross-functional team comprised of regulatory affairs , clinical development, clinical operations, biostatistics, pharmacology, ... focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies. Must have experience in global regulatory … more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ... to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek...cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities… more
- BeOne Medicines (Cambridge, MA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director , Regulatory Affairs in Cambridge, MA, USA: **Job Duties:** + Provides high level regulatory ... FDA Health Authority interactions. + Uses extensive knowledge of US , and ICH regulatory requirements and applies...Uses extensive knowledge of US , and ICH regulatory requirements and applies this knowledge both strategically and… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... Your skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** Are ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for ... appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you will contribute:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee...where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …stem cell transplant. In this position you will build and lead a cell medicine regulatory affairs team and provide regulatory leadership and oversight to the ... development of innovative regulatory affairs and CMC regulatory ...and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic… more
- United Therapeutics (Boston, MA)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... or pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing innovative global ... the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Danaher Corporation (Boston, MA)
- …compliance, driving innovation and excellence in the Biopharma sector. This position reports to the Director , Regulatory Affairs and is part of the Global ... m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Canon USA & Affiliates (Boston, MA)
- … Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs , the Regulatory Affairs Specialist ... Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry...salary of $72,000 to max $116,100 (annual equivalency) **_About us !_** _Canon Medical Systems USA, Inc., a world leader… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... regulatory filings for cellular & gene therapy projects (CAR T cell therapy) both in the US and internationally for our growing oncology franchise. In this… more
