- Merck & Co. (Boston, MA)
- …discovery and development (MIDD) to routinely enable efficient drug discovery/ development and/or regulatory decisions. The Pharmacometrics group within QP2 ... and bringing subject matter expertise related to model informed drug discovery and development for programs .- The Senior Director in Pharmacometrics should… more
- Merck & Co. (Boston, MA)
- …and the further study of marketed compounds.Support of business development assessments of external opportunitiesThe Senior Director May: Supervise the ... development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May… more
- Repligen (Waltham, MA)
- …Partner with senior leaders to embed strong controls into business processes Mentor and develop a world-class compliance teamResponsibilitiesGlobal Compliance ... (Finance, IT, Legal, Operations) to embed robust controls into business processes.Strategic Oversight & Program Management:Formulate and execute strategic… more
- Eisai, Inc (Boston, MA)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... partners. Key job activities include territory and market analysis, strategic business planning, self-driven execution of plans, meeting with key stakeholders,… more
- Cardinal Health (Boston, MA)
- …post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a ... medical device companies get their products to market. Our regulatory and product development strategies are designed...sales process effectively through to closure and beyond. This Director , Business Development , is responsible… more
- AbbVie (Waltham, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible ... with global regulatory requirements. Manages compounds through all phases of development , including post approval and throughout the life cycle of the product.… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will provide strategic ... are effectively implemented and maintained in line with changing regulatory and business needs. + Ensures project...+ Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development… more
- Rhythm Pharmaceuticals (Boston, MA)
- …on multi-disciplinary project teams and provide strategic regulatory guidance on development plans + Prepare regulatory development plans for assigned ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be...degree in life sciences preferred + 8+ years of Regulatory Affairs experience in drug development and… more
- Evident Scientific (Waltham, MA)
- Executive Director , Regulatory Affairs & Quality Assurance. Job ID #: 2023 Company: Evident Posting Date: Jun 3, 2025 **Working Location:** **MASSACHUSETTS, ... every day. **Let's inspire healthier lives, together.** **Job Description** The Executive Director , Quality and Regulatory Affairs (Exec Dir QARA), will oversee… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... regulatory nuances and requirements. - Understanding of scientific principles and regulatory /quality systems relevant to drug development . - Ability to… more
- Takeda Pharmaceuticals (Boston, MA)
- …within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations ... are effectively implemented and maintained in line with changing regulatory and business needs. + Direct point...+ Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development… more
- Takeda Pharmaceuticals (Boston, MA)
- …: Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with the following duties: Oversee the ... for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION DESCRIPTION**… more
- Sanofi Group (Cambridge, MA)
- …stakeholders including clinical, medical affairs, R&D, Manufacturing & Supply (device development , manufacturing, quality, supply chain) and Global Business ... get started? **Main Responsibilities:** + Lead, supervise and coach a team of regulatory professionals and be responsible for the development of direct reports… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …and advises product teams of the impact on the business or development programs. + Responsible for regulatory review and perspective on BD opportunities ... the Regeneron Cell Medicines, based in Cambridge, MA, a business unit for Regeneron Pharmaceuticals Inc to help advance...cell medicine regulatory affairs team and provide regulatory leadership and oversight to the development … more
- Takeda Pharmaceuticals (Boston, MA)
- …strategy and coordinating life cycle activities across the portfolio of PDT products. The Global Regulatory Lead, Director , in PDT R&D: + Serves as the global ... MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development , innovative trial design and/or expedited regulatory pathways… 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 ... this position you will be responsible for driving the development of innovative CMC regulatory strategies and...impose undue hardship on the operation of the Company's business . For roles in which the hired candidate will… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and ... that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 TAU within… 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 shape ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...and evaluates the impact on external environments and the business . + Develops and implements regulatory strategies… more
- Fresenius Medical Center (Waltham, MA)
- …and other functional areas to align regulatory strategy with overall product development and business objectives. + Provide expert guidance on regulatory ... Strategy Leader will work closely with internal and external stakeholders to align regulatory strategies with business objectives and drive the timely delivery… more
