- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … 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
- Evident Scientific (Waltham, MA)
- Executive Director , Regulatory Affairs &...applicable federal, state or local law. Posting Notes: || United States ( US ) || Massachusetts ... **Let's inspire healthier lives, together.** **Job Description** The Executive Director , Quality and Regulatory Affairs (Exec Dir QARA), will oversee the… 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
- 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
- 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
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more
- AbbVie (Waltham, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory Lead, ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic… more
- Merck (Boston, MA)
- **Job Description** The Director /Principal Scientist, Regulatory Affairs Liaison, is responsible for the development and implementation of worldwide ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and...in certain states and cities within the United States . Final determinations with respect to… 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
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** About the role Join Takeda as an Associate Director , US Medical Affairs Sponsorship where you will strategically develop ... and oversee the annual US Medical Affairs sponsorships and corporate membership...audiences. * Comprehensive knowledge and experience with legal and regulatory guidelines related to sponsorships and corporate memberships for… 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 (Worcester, 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Medical Affairs Director - Evidence Generation, Respiratory **Location:** Cambridge, MA Our Medical function serves as a valued strategic partner ... with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support...years' experience in industry preferably in R&D or Medical Affairs . + Prior experience in Clinical trials, including understanding… more
