- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, ... this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC ,… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC , New Products, Sales & Marketing, and ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… 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 ... Manager , CMC Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management in Lexington, MA with ... 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)
- …Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA with the following ... requirements: Master's degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory… 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** ... all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a...manufacturing and quality programs throughout product lifecycle. + Provide CMC regulatory strategy for products manufactured at… 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. ... **the** **job:** . Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic... Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible ... people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help develop … more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program ... regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC ...to support their development + May serve as direct/matrix manager of RAV CMC staff, depending on… more
- Insight Global (Rahway, NJ)
- …Facilitate communication and collaboration among cross-functional teams, including R&D, Quality, Regulatory Affairs , IT, and Manufacturing. Budget and Resource ... project management within the pharmaceutical or biotechnology industry, Strong knowledge of CMC processes, regulatory requirements, and quality standards in the… more
- Ascendis Pharma (Palo Alto, CA)
- …perspectives to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and ... Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key Responsibilities + Responsible for.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… 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 ... develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is...ensure alignment with overarching PHB business strategies. + Provide regulatory leadership with expertise in CMC and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the Senior Director, Commercial Regulatory Affairs , in collaboration with Head, Regulatory Affairs and CMC -RA, will review and assess all commercial ... hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development...and non-promotional materials. + Collaborates closely with the PMRC Manager and other members to quickly resolve issues that… 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, ... -Analyze the regulatory pathway and history (including competitive regulatory analysis) by researching pre-clinical, clinical, CMC and post-marketing… more
- ThermoFisher Scientific (High Point, NC)
- …contract manufacturing activities (CMO) and development of mainly generics OTC products. The regulatory manager will lead site regulatory activities related. ... -approval + Experience with publishing software for eCTD submissions. + Regulatory Affairs Certification (RAC or equivalent) strongly preferred **Competencies**… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, ... this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC ,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more
- J&J Family of Companies (Titusville, NJ)
- …of new product launches globally, collaborating with Manufacturing, Regulatory Affairs , Quality Assurance, Compliance, Finance, Marketing, and CMC to drive ... Senior Manager , Supply Chain Development Leader - 2406191460W **Description**...cross-functional teams is required + Knowledge of global pharmaceutical regulatory /compliance guidelines is required + Ability to communicate effectively… more
- Rush University Medical Center (Chicago, IL)
- …input to his/her supervisor to identify areas of opportunity within the manager 's scope, escalate risk and resolve barriers. This position will provide direction, ... communicates with Revenue Cycle colleagues, study teams, patients, Office of Research Affairs , IRB, RUMC Compliance, and all partners in the Research Continuum. *… more
- Taiho Oncology (Princeton, NJ)
- …(Clinical Studies, CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs , HEOR, CMC and other related ancillary providers etc.) sourcing ... Sr. Manager , Outsourcing & Vendor Management Princeton, NJ, USA...negotiation, and project award. + Ensures compliance with all regulatory and reporting requirements related to Supplier Diversity and… more
