- AstraZeneca (Boston, MA)
- Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the development and implementation of ... global regulatory strategies for all assigned products...Senior Management and Enterprise functions (eg Clinical, Commercial, Medical Affairs , amongst others) to provide portfolio or therapeutic level… more
- PharmaEssentia USA (Burlington, MA)
- Position Overview: The Associate Director , Government Pricing and Reporting, will be a critical member of the Finance Team reporting to the Head of Finance. The ... (eg, Medicare, Medicaid, 340B). This role ensures accurate pricing models, regulatory compliance, and timely reporting to optimize reimbursement and minimize risk.… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …functions (eg project management, clinical monitoring, data management process, regulatory affairs , pharmacovigilance, etc.) to enable meaningful dialogue ... and empower you to shine? Join us as the Director , Supplier Relationship Management (FSP) based in Cambridge, MA...towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work… more
- Vertex Pharmaceuticals (Boston, MA)
- …liaison between Clinical Development and other internal groups at Vertex (eg, Regulatory Affairs , Clinical Operations) for assigned studies Represents Vertex to ... Job Description General Summary: The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... Your skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for ... andbuilding appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion ... 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:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing ... Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Fresenius Medical Center (Waltham, MA)
- …+ 12+ years of experience in regulatory affairs , focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. + ... Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical...a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred.… more
- Takeda Pharmaceuticals (Boston, MA)
- …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals… more
- Rhythm Pharmaceuticals (Boston, MA)
- …commercialization and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… 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 ... experienced Medical Director of CNS Early Assets, Global Medical Affairs , responsible for certain assets...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC) for investigational and ... this key leadership role, you will build and oversee Global Regulatory Science and Regulatory ...position you will build and lead a cell medicine regulatory affairs team and provide regulatory… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** : Reporting to the Vice President, Global Medical Affairs , the Executive Director , CNS Strategy, Global Medical Affairs is a ... but are not limited to the following: + Represents Global Medical Affairs on extended brand leadership...Otsuka prominence in CNS space + Provides input into regulatory documents, including product labeling + Accountable for resourcing… more
- Takeda Pharmaceuticals (Boston, MA)
- …grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications ... in coordination with relevant cross-functional teams (including members of medical affairs , clinical development, and outcomes research; global , regional, or… 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 to ... 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
