- 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)
- …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
- 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
- Bayer (Cambridge, MA)
- …brilliant and diverse minds to make a real difference, there's only one choice.** **Senior Director , Global Regulatory Leader-IVD** The Senior Director , ... **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Senior Director , Global Regulatory Leader-IVD are to: **Develop and… 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
- AbbVie (Waltham, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… 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 ... US FDA and provides support for regional and local regulatory affairs teams for interactions with international...and/or other regional counterparts in compiling global regulatory strategies and works cross-functionally with RA … 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
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team...PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry.… 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
- 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
- Bristol Myers Squibb (Cambridge, MA)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Medtronic (Boston, MA)
- … Regulatory department and other business functions. This position reports to the Regulatory Affairs Director . Location: Strong preference to have a ... world. **A Day in the Life** The Senior Principal Regulatory Affairs Specialist will play a key...new product development and sustaining teams to develop the global regulatory strategy and support regulatory… more
- Liberty Utilities (Fall River, MA)
- Manager, Rates and Regulatory Affairs Fall River, MA, US, 02720 **Our purpose is sustaining energy and water for life, and it is demonstrated in everything we do ... the East region. This position is responsible for all regulatory affairs and rates related functions in...in multiple jurisdictions. The Manager will support the Regional Director , on other regulatory matters and organizational… more
- Merck (Boston, MA)
- …Development Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** The Director /Principal Scientist, Regulatory Affairs ...Compliance Programs, Cross-Functional Teamwork, Drug Development, Economic Impact Analysis, Global Regulatory , Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …with applicable regulatory requirements. Serve as the expert for device labeling on the global Regulatory Affairs ( RA ) Sub team and Global ... to bring life-changing therapies to patients worldwide. As Associate Director , Global Labeling Devices, you will be...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more