- 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
- 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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …understanding of basic and intermediate statistical tests.Good understanding of GxP, CMC , ICH and compendial (USP/EP/JP) regulatory requirements.Proficient in ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory… 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
- BeiGene (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential** **Functions** **of** **the** **job:** . Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC … 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
- Insight Global (Rahway, NJ)
- …project management within the pharmaceutical or biotechnology industry, Strong knowledge of CMC processes, regulatory requirements, and quality standards in the ... Job Description We are seeking an experienced Program Manager to provide administrative support and oversee the strategic implementation of our CMC digitization… more
- Charles River Laboratories (Rockville, MD)
- Senior Project Manager CMC Req ID #: 223438 Location: US For 75 years, Charles River employees have worked together to assist in the discovery, development and ... you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs, Marketed Products in Cambridge, ... the regulatory pathway and history (including competitive regulatory analysis) by researching pre-clinical, clinical, CMC ...Health Canada, and other international health authorities - Support regulatory team and Global Regulatory … more
- 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
- Ascendis Pharma (Palo Alto, CA)
- …, Regulatory Affairs will be responsible for supporting and developing global regulatory strategies for both development and commercial products encompassing ... Regulatory Affairs. Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... regulatory agencies, cross-functional teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is… more
