- 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
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate 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
- 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
- Merck (Boston, MA)
- **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The ... updates. + Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory … 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)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director CMC Regulatory Affairs is responsible for ensuring ... communicate and negotiate with international Health Authorities, representing Takeda Global Regulatory Affairs CMC in meetings + Provide strategic direction… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care...compliance with Sanofi's behavioral and ethical standards **Why Choose Us ?** + Bring the miracles of science to life… more
- J&J Family of Companies (Raynham, MA)
- …MD **Job Category:** Scientific/Technology **All Job Posting Locations:** Raynham, Massachusetts, United States of America **Job Description:** Johnson and ... Johnson is currently seeking a **Medical Director , Medical Affairs , Orthopedics (Spine)** located **in...cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical ... + May represent Medical Affairs at certain US and Global governance meetings. The Director ...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- We are seeking a Senior Director , Federal Government Affairs to lead our US federal government engagement in Washington, DC. This position reports to the ... the strategic leader, and a member of the Government Affairs Leadership Team, the Senior Director of...Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to… more
- Grifols Shared Services North America, Inc (Boston, MA)
- …Medical Affairs Scientific Director 2 role based in the United States (non-California), is $240,000.00 - $330,000.00 per year/per hour. Additionally, the ... and commercial functions. 2. Support development of global and US medical affairs plans in alignment with...drives to site locations with occasional travel within the United States . Able to communicate information and… more
- Takeda Pharmaceuticals (Boston, MA)
- …and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Hematology. ... development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead, Hematology** proactively defines and drives… more
- Liberty Utilities (Fall River, MA)
- Manager, Rates and Regulatory Affairs Fall River, MA, US , 02720 **Our purpose is sustaining energy and water for life, and it is demonstrated in everything ... the East region. This position is responsible for all regulatory affairs and rates related functions in...in multiple jurisdictions. The Manager will support the Regional Director , on other regulatory matters and organizational… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Associate Director , US Advertising & Promotion Regulatory Review** **Takeda ... Pharmaceutical** **USA-MA-Virtual** **About the role:** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review. Where you will be… more
- Takeda Pharmaceuticals (Boston, MA)
- …lead interface with the US FDA and support regional and local regulatory affairs teams with health authority interactions + Demonstrated ability to develop ... activities across the portfolio of PDT products. The Global Regulatory Lead, Director , in PDT R&D: +...in which biopharmaceutical companies operate + Extensive experience in US and/or International Regulatory Affairs ,… more