- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC ,… more
- Aequor (NJ)
- …/ Strong knowledge of the global drug development process and global regulatory requirements. Proficient and strong analytical skills. Strong communication ... and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC , QA, Packaging Vendors, CRO's, IRT Organizations, and… more
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug Development...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization ... integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas)… more
- EY (New York, NY)
- …have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And ... teams and stakeholders.Ensure all clinical trial activities comply with regulatory standards.Prepare comprehensive reports of clinical trial results, and present… more
- J&J Family of Companies (Titusville, NJ)
- Manager Global CMC Regulatory Affairs - 2406185933W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Manager , CMC ... regulatory expertise to these teams and global regulatory teams. + Ensures that CMC regulatory strategy is aligned with strategies of global… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management in Lexington, MA ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA with the following ... phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided… more
- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory ... of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences, a...marketing applications. + Support the development and execution of CMC regulatory strategies for global … more
- Teva Pharmaceuticals (West Chester, PA)
- …for maintaining and updating CMC sections of submissions for assigned products. As Manager CMC Regulatory Affairs you will also be responsible for ... Manager , CMC Regulatory Affairs... Manager , CMC Regulatory Affairs - Remote OR...(eg, FDA, Health Canada) as well as working with global regulatory colleagues in preparing dossiers for… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Manager , CMC Regulatory Sciences for Clinical Submissions leads a team that manages the CMC regulatory submission work across multiple clinical ... programs and/or submissions. As a Manager , CMC Regulatory Sciences ,...cross functional teams, contract manufacturing organizations, as well as global regulatory partners. + Oversees (in collaboration… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Commercial Post Approval CMC Regulatory Sciences Associate Manager position responsible for providing Chemistry, ... Assisting in preparation for meetings with global regulatory authorities. + Contributing to developing CMC ...device, including some supervisory and/or leadership experience. + Associate Manager : Requires 6+ years of relevant experience + … more
- Amgen (New Albany, OH)
- …patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager , CMC . **Live** **What you will do** Let's ... for product manufacturing and quality programs throughout product lifecycle. + Provide CMC regulatory strategy for products manufactured at or planned for… more
- Teva Pharmaceuticals (West Chester, PA)
- …difference, and new people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help ... major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for... Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for identifying… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of ... to support their development + May serve as direct/matrix manager of RAV CMC staff, depending on...CMC submissions. + Understanding of scientific principles and regulatory CMC requirements relevant to global… more
- Regeneron Pharmaceuticals (Troy, NY)
- …* Participate in global RA meetings and help to develop regulatory strategies to support CMC /CP activities. Participation in communications between ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager , Regulatory Affairs for Chemistry Manufacturing & Controls ( CMC ) works with ... affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand...the regulatory affairs department under supervision of manager . Participates in initiatives internal to RA CMC… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Associate Director** **; CMC , Device Development Program Manager ** **Functional Area: Technical Operations** At ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and… more
