- Pulmovant (New York, NY)
- …each meticulously tailored to address a specific medical need. Summary The Head of Regulatory Affairs and Quality is responsible for leading the global ... member to the company's senior management team, managing activities across the regulatory affairs and quality assurance and control organization (GxP). Key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Mannkind Corporation (Boston, MA)
- Position: Executive Director/Vice President, Head of Regulatory Affairs Location: Boston, MA Job Id: 11071 # of Openings: 1 At MannKind our employees are our ... Position Summary: MannKind Corporation is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs . Reporting to MannKind's Chief… more
- MannKind Corp (Boston, MA)
- …better.Position Summary:MannKind Corporation is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs . Reporting to MannKind's ... will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. They will be a key member of the project… more
- Orca Bio (Menlo Park, CA)
- …blood and immune systems with healthy ones, but also restore their lives.The (Sr.) VP/ Head of Regulatory Affairs will lead the company's regulatory ... regulatory plans for Orca Bio's product pipeline. The SVP/ Head of Regulatory will provide oversight of...ensure alignment and timely feedback.Build, mentor, and lead the Regulatory Affairs team, ensuring team members are… more
- Ironwood Pharmaceuticals (Boston, MA)
- …either directly or through delegation to staff/contractors. Lead the Regulatory Affairs -CMC function to prepare and submit high- quality regulatory CMC ... staff/contractors. This should be performed in collaboration with Technical Operations, Quality , and Regulatory Affairs functions to meet company and project… more
- Friends (Boston, MA)
- …new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key ... and regulatory data and information.Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on key strategic, portfolio,… more
- Takeda Pharmaceutical (Boston, MA)
- …new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key ... regulatory data and information. Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on key strategic, portfolio,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …team productivity, customer experience and operational efficiency. Consults with legal and regulatory affairs to address legal considerations and ensure AI ... experiences for patients and customers. Relationships Reports to the Head of Commercial Excellence and Innovation. Collaborates with cross-functional teams,… more
- Adverum Biotechnologies (Redwood City, CA)
- The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key ... development, regulatory , and registration strategies. What you'll do:Manage the Regulatory Affairs (CMC) Strategy for Regulatory AffairsStrengthen… more
- BioSpace (Boston, MA)
- …overall functional performance over time and for future planning. Develop and maintain a Regulatory Affairs Quality Management System including a system for ... Job Description The Head of Regulatory Operations at Takeda...will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy… more
- Takeda Pharmaceutical (Boston, MA)
- …overall functional performance over time and for future planning. Develop and maintain a Regulatory Affairs Quality Management System including a system for ... to the best of my knowledge. Job Description The Head of Regulatory Operations at Takeda will...will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy… more
- Genmab A/S (Princeton, NJ)
- …seeking a Senior Director, USMA Solid Tumor Portfolio. This role will report to the VP/ Head of US Medical Affairs and will be responsible for building and ... and highest quality standards are applied to all US Medical Affairs solid tumor portfolio related work.Responsible for ensuring compliance and accountable for… more
- Rhythm Pharmaceuticals, Inc (Boston, MA)
- … Quality Assurance organization. This role reports into the SVP, Global Regulatory Affairs and GCP/GLP QA.Responsibilities and DutiesLead the clinical ... areas for improvement.Collaborate with cross-functional teams, including clinical operations, regulatory affairs , pharmacovigilance, and other relevant departments,… more
- Optimapharm (Boston, MA)
- …American OperationsCoordinate communication and collaboration between North American Operations and Head of Departments (PM, Clinical Operations, Regulatory and ... of the company. We are looking for an ambitious Head of Clinical Operations, a strong, charismatic leader with...Start-up, Trial Support, DM, Biostatistical Services, Medical Affairs and Quality Assurance) and clients to… more
- Dennis Partners (Boston, MA)
- …CROs and other service providers used to support the clinical development programs.Build a strong Regulatory Affairs and Quality team to meet the needs of ... They are seeking a Vice President (or SVP) of Regulatory & Quality to build and lead...time to join this growing organization!Responsibilities:Build and lead the Regulatory Affairs function to ensure adherence to… more
- Pendulum (San Francisco, CA)
- …the quality function at Pendulum. This role will report to the VP of Regulatory Affairs and Quality . What You'll Do:Ensure cGMP compliance against 21 CFR ... with internal business partners (including Manufacturing, Supply Chain, Process Development, Regulatory Affairs ) to deliver the innovation pipeline and meet… more
- Pendulum (TM) (San Francisco, CA)
- …the quality function at Pendulum. This role will report to the VP of Regulatory Affairs and Quality . What You'll Do: Ensure cGMP compliance against 21 ... We are seeking a Senior Director to serve as Quality Site Head and lead Pendulum's in-house...internal business partners (including Manufacturing, Supply Chain, Process Development, Regulatory Affairs ) to deliver the innovation pipeline… more
- CLevelCrossing (Washington, DC)
- …or a related field.Minimum of 4 years of experience in compliance or regulatory affairs , including some experience in the commodities sector.Strong knowledge of ... individuals can predict event outcomes and make money at the same time through head over heart investing in outcomes of mainly political events. AIEX expects to… more
- Accenture (Seattle, WA)
- …of the following areas: research, clinical development / operations, pharmacovigilance, regulatory , medical affairs , medtech, patient services, MD&D (medical ... and are creative in inspiring teams to turn in quality work on time, every time. You have interest...analysis of their current product development and R&D strategies Head up teams designing and deploying solutions focusing on… more
