- Novo Nordisk Inc. (Boulder, CO)
- …we are driving change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical...raw materials, during the execution of his/her duties, the Manager / Senior Manager should seek to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as... Affairs, as well as cross-functional stakeholders (eg, RA CMC , R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and… more
- Tris Pharma (Monmouth Junction, NJ)
- …globally. We have an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ... This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC , New Products, Sales & Marketing, and Legal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC , IP, patient selection, ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Bristol Myers Squibb (Summit, NJ)
- …(including participating / leading HA meetings); &/or post-approval submissions. In this role, the CMC Regulatory Manager will serve as the primary interface ... a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key... Sciences (GRS) & Global Product Supply (GPS) The GRS- CMC senior manager will assess… 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...throughout product life cycle. Escalate the critical issues to senior management timely. . Lead or contribute to development… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC ... Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for identifying and ... at Teva (both development and marketed products) ⦁ Provide accurate and timely CMC regulatory guidance to teams engaged in the development of new products by… 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, ... global regulatory authorities. + Contributing to developing CMC regulatory strategy. This role may be...Manager : Requires 7+ years of relevant experience + Senior Manager : Requires 8+ years of relevant… 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 ... with regulatory agencies, cross-functional teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development ... marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and… more
- Bristol Myers Squibb (Summit, NJ)
- …a member of a cross functional team responsible for drug product related CMC strategy development. **Key Responsibilities** The Senior Principal Scientist will ... and support the generation of appropriate responses to questions from regulatory authorities. **Key Responsibilities** The Senior Principal Scientist will… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a Scientific ... of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for...in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs. Key Responsibilities +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** The Regulatory Data Manager will be a key member of the Global ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the product/program, and ensures visibility and communication of key project timelines and CMC milestones + Acts in a project manager capacity to ensure:, ... safe life-changing therapies. **Job Summary:** Gilead Sciences seeks a Sr. Manager , Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM)… more
- University of Colorado (Aurora, CO)
- QA Senior Manager - 33670 University Staff...+ Serve as the QA point of contact in CMC and Process Development and direct QA functional areas ... Anschutz Medical Campus** **Department: Gates Biomanufacturing Center** **Job Title: QA Senior Manager ** **Position #: 00803572 - Requisition #:33670** **Job… more
- Taiho Oncology (Princeton, NJ)
- …team at Taiho Oncology where innovation thrives, and excellence is celebrated. As a Senior Manager in Analytical Development, you'll play a pivotal role in ... Sr. Manager , Analytical Development Princeton, NJ, USA Req #362...to ensure methods are developed and qualified to meet regulatory requirements, interacts with QA/ Regulatory / CMC … more
- Novo Nordisk (Lexington, MA)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in ... Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development,… more
- BD (Becton, Dickinson and Company) (Vernon Hills, IL)
- …as well as R&D, Manufacturing, Sales, Marketing, Operations, and Finance. The Senior Quality Engineer interacts with Regulatory Affairs regarding new regulations ... **Job Description Summary** The Senior Quality Engineer is responsible for supporting Design... Quality Engineer works closely with shared functions (eg Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance,… more
- BeiGene (San Mateo, CA)
- …in compliance with evolving electronic data standards. This role which reporting to the Senior Manager RIMT is a critical member of the RIM Data Quality ... **General Description:** The Associate Manager (AM), Regulatory Information Management (RIM)...outside of the department including RegTech, business partners (eg CMC , Labeling SMEs) to ensure effective communication and efficient… more
- The Arora Group (Bethesda, MD)
- …Manager (RN-NCM) + National Academy of Certified Care Managers: Care Manager Certified ( CMC ) + Experience: + Referral Management/Utilization Management ... Registered Nurse Case Manager Nurse Currently recruiting a Registered Nurse (RN)...in obtaining services and support. + Serve as a senior nursing leader and advances the nursing profession in… more
