- MannKind Corporation (Bedford, MA)
- …Updates, patient narratives, and manuscripts for peer-reviewed publications. Stay abreast of global regulatory requirements and guidelines (FDA, EMA, PMDA, ICH, ... and best practices. Partner with cross-functional teams, including clinical development, medical affairs , regulatory affairs , safety to ensure seamless… more
- Deciphera Pharmaceuticals (Waltham, MA)
- …support key decision-making, drive conclusions and develop next steps Work closely with Regulatory Affairs , and other cross functional team members to ensure ... will be located in the Waltham office. The Medical Director is responsible for global pharmacovigilance (PV)...and other periodic reports Contribute to preparation of relevant regulatory documents and responses to regulatory agency,… more
- LanceSoft (Cambridge, MA)
- …working cross functionally and leading the development of required processes (eg, with Global Regulatory Affairs , Data Sciences). Ensures that Client Signal ... Job Title: Director , Signal Management Location: Cambridge, MA 02139 -...and activities are compliant with EU regulations and EU regulatory authority and inspectors' expectations. Principal responsibilities include: Technically… 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)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... CMC development and registration strategies. You will be RA CMC member on Regulatory , Pharmaceutical Development,...Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by… 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are ... possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand… 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 (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 ... regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and...a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (eg, Growth… 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
- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Sumitomo Pharma (Boston, MA)
- …, Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...function as the Regulatory reviewer for assigned products. This position is responsible… 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
- 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
- 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 ... expedite approvals of product and labeling changes. + Maintains awareness of global regulatory environment and assess impact of changes on business and product… more
- Danaher Corporation (Boston, MA)
- …sector. This position reports to the Director , Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote. In ... pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in… more
