- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible ... 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)
- …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
- AbbVie (Waltham, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination… 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
- 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),… 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
- J&J Family of Companies (Raynham, MA)
- …+ Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... America **Job Description:** Johnson and Johnson is currently seeking a **Medical Director , Medical Affairs , Orthopedics (Spine)** located **in Raynham, MA.**… 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 ... it will engage with other business units and functional groups, such as Global Medical Affairs , Oncology, and Medical & Commercial teams. * Embedded… more
- Grifols Shared Services North America, Inc (Boston, MA)
- …plans in Immunology- and Infectious Disease-related therapeutic areas. Develop and lead Medical Affairs initiatives and strategies aligned with the global and US ... Innovation Office and commercial functions. 2. Support development of global and US medical affairs plans in...**Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… 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...improve the lives of patients. We are an innovative global healthcare company with a focus on immunology that… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … 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 regulatory lead for one or more projects and and...US FDA and provides support for regional and local regulatory affairs teams for interactions with international… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will provide ... **How you will contribute:** + Defines, develops, and leads global strategies to maximize global regulatory...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more