- AstraZeneca (Boston, MA)
- …and considered an equal partner in the business. The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible ... functions through the recruitment of Regulatory Affairs Strategists (at Director and Senior...for overseeing the development and implementation of global regulatory strategies for assigned products in… more
- Proclinical Group (Boston, MA)
- Senior Director , Regulatory Affairs - Perm - Boston, MAProclinical is seeking a dynamic and strategic leader for the role of Senior Director of ... manage complex regulatory portfolios.Strong leadership skills and strategic thinking.The Senior Director , Regulatory Affairs ' responsibilities will… more
- Mannkind Corporation (Boston, MA)
- …product management Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and ... Position: Executive Director /Vice President, Head of Regulatory Affairs Location: Boston, MA Job...Clinical Team to develop and implement the US and global regulatory affairs plan across… more
- Dennis Partners (Boston, MA)
- …therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and ... execute on global regulatory strategies for an early-stage Rare Disease program. In...and other regulatory agencies in conjunction with senior Regulatory leaders.Author/edit documents to support … more
- MannKind Corp (Boston, MA)
- …product management.Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices, ... the better.Position Summary:MannKind Corporation is currently seeking an Executive Director /Vice President, Head of Regulatory Affairs...Clinical Team to develop and implement the US and global regulatory affairs plan across… more
- Travere Therapeutics (Boston, MA)
- …and service for rare patients.Position Summary:The Executive Director , Regulatory Affairs will develop and execute global regulatory strategic and ... limited to the use of regulatory tools in developing accelerated global regulatory approval strategies using novel endpoints, biomarkers or alternative… more
- AstraZeneca (Boston, MA)
- …the best submission practices and knowledge. Effectively represent the Global Regulatory Affairs function in senior level interactions at internal ... can grow and thrive. The Executive Director , Regulatory Science & Strategy provides global strategic... Affairs Directors (US and EU regional regulatory leads) and Senior Directors ( global… more
- Xenon Pharmaceuticals Inc. (Boston, MA)
- …teams, as well as with key internal stakeholders such as Finance, Clinical Operations, Regulatory Affairs , and Quality Assurance. This position reports to the ... Senior Director , Supply Chain Systems and will...International Conference on Harmonization (ICH) Guidelines and other relevant global pharmaceutical regulations, guidelines and directives.Experience with Master Data… more
- Vertex Pharmaceuticals (Boston, MA)
- …teams, including R&D, external manufacturing, quality control, vendor quality and regulatory affairs , to align sourcing activities with production schedules, ... Strategic Sourcing Associate Director , Cell and Gene Therapy Raw Materials (hybrid)...the organization, so the ability to effectively communicate with Senior Executive leaders is crucial.Execution responsibilities include market analysis… more
- AVEO Pharmaceuticals (Boston, MA)
- …The Director will collaborate cross-functionally with clinical development, regulatory affairs , commercial teams, and external stakeholders to support ... JOB TITLE: Director of Pharmacovigilance Quality and Alliance ManagementLOCATION: Boston...Quality Management System (PV QMS) to ensure compliance with global regulatory requirements (eg, FDA, EMA, ICH).Lead… more
- Page Mechanical Group, Inc. (Boston, MA)
- …The Director will collaborate cross-functionally with clinical development, regulatory affairs , commercial teams, and external stakeholders to support ... JOB TITLE: Director of Pharmacovigilance Quality and Alliance Management LOCATION:...Quality Management System (PV QMS) to ensure compliance with global regulatory requirements (eg, FDA, EMA, ICH).… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation ... where you will define, develop and lead global strategies to maximize global ...their regional counterparts. **How you will contribute:** + The Senior Director will be responsible for complex… more
- AbbVie (Cambridge, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, ... GRS, is responsible for the management of global regulatory leads with product and disease...may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... where you will oversee the development and execution of regulatory CMC development and registration strategies. RA ...Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by… more
- AbbVie (Waltham, MA)
- …with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director , or Director ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule where you will… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 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 (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …life-changing therapies to patients worldwide. **How you will contribute:** + The Senior Director , Pharmaceutical Sciences (PS) Portfolio Leader is accountable ... engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs + Has knowledge of fundamental… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … regulatory guidance on Material Sciences to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... with line management + Supports and/ or leads assigned device-related aspects of global regulatory submissions (eg, Core Dossiers, INDs, CTAs, BLAs, MAAs,… more
