- 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
- 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 (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
- Takeda Pharmaceuticals (Lexington, 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
- 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
- Grifols Shared Services North America, Inc (Medford, 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
- Charles River Laboratories (Wilmington, MA)
- …pharmaceutical and/or biotechnology-related industry having direct responsibility for QA/ Quality Control/ Regulatory Affairs . Minimum of 5 years oversight of ... a career that you can feel passionate about. **Job Summary** The Senior Director Global Head of Biologics Testing Quality will provide direction and leadership as… more
- Sanofi Group (Cambridge, MA)
- …**Location** : Cambridge, MA, Morristown, NJ, **About the Job** Sanofi is recruiting a Director US Medical Affairs . The Director will report ... to the Head of US Medical Affairs , Rhinology/ Gastroenterology. This position is based in Morristown,...+ Reviewing and approving medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Takeda Pharmaceuticals (Lexington, MA)
- …tactics and activities, in an independent manner, closely coordinated with the Director US Medical Communications. * The Medical Communications Associate ... member of the Scientific Communications Team reporting to the Director US Medical Communications for the assigned...SCPs for new products * In collaboration with the US Medical Affairs team, support development and… more
- J&J Family of Companies (Cambridge, MA)
- …Sciences **Job Category:** People Leader **All Job Posting Locations:** Cambridge, Massachusetts, United States of America, San Diego, California, United ... States of America, Spring House, Pennsylvania, United States of America **Job Description:** Our...human data resources. + Partner with Clinical Development, Global Regulatory Affairs , Data Science, Patient Reported Outcomes,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Associate Director , Clinical Research, Value & Evidence Generation, US Medical** **Lexington, ... and leadership to ensure successful operational execution of all US Medical Clinical Research including, Medical Affairs ...internal legal and compliance policies as well as external US -specific regulatory guidelines. + Partners with … more
- J&J Family of Companies (Danvers, MA)
- …(Commission) **Job Category:** People Leader **All Job Posting Locations:** Danvers, Massachusetts, United States of America, St. Louis, Missouri, United ... Abiomed team located in St. Louis, Missouri in the United States . This is a field-based role...but not limited to Operations, Finance, Marketing, Human Resources, Regulatory , and Clinical Affairs + Liaise with… more
- Sanofi Group (Cambridge, MA)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... **Job title** : Global Medical Director , Evidence Generation - Innovation & Partnerships **Location:**...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- Grifols Shared Services North America, Inc (Medford, MA)
- …pay scale for the Medical Director (1-2) role based in the United States (non-California), is $170,000.00 - $240,000.00 per year/per hour. Additionally, the ... study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve...drives to site locations with occasional travel within the United States . Able to communicate information and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …communications tactics and activities, in an independent manner, closely coordinated with the Director US Medical Communications. In this role you will interact ... of my knowledge. **Job Description** Join Takeda as Associate Director , US Medical Communications Dermatology/Immunology out of...SCPs for new products + In collaboration with the US Medical Affairs team, support development and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …communication plans through close collaboration with cross-functional teams (including Medical Affairs , Clinical Development, Regulatory Affairs , Commercial, ... + Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated...or local minimum wage requirements for the job location. US based employees may be eligible for short-term and/… more
- Sanofi Group (Cambridge, MA)
- …MSLs, Region Central have to work closely with Commercial partners while minding regulatory boundaries for non-promotion + Director , Allergy MSLs, Region Central ... **Job Title:** Director , Allergy MSLs, Region Central **Location** : Remote...priorities into specific goals and expected outcomes for the US region and individual MLs. + Supervise identification and… more
- Sanofi Group (Cambridge, MA)
- …Regulatory data, data models, and systems along with an understanding of regulatory affairs life cycle (eg, new product registrations, variations, extensions, ... regulatory data. This role reports to the Sr. Director of Data Readiness and Quality. We are an...years' experience in the bio/pharmaceutical industry with experience in Regulatory Affairs . + Strong knowledge of … more