- 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
- Merck & Co. (North Wales, PA)
- …in the Research & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug ... integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas)… 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
- EY (New York, NY)
- …your career.Your key responsibilitiesWe are searching for an experienced and dynamic Senior Clinical Trial Developer and Modeler to join our team. The successful ... teams and stakeholders.Ensure all clinical trial activities comply with regulatory standards.Prepare comprehensive reports of clinical trial results, and present… 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
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... Job DescriptionThe drug development Project Manager is part of Global Project and Alliance...they need.Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects. Sharing… 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
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, ... product(s) with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, in… 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
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located ... regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC... Regulatory Leads (GRLs) (Global Product Strategy or CMC ) and team members to enhance these relationships. +… 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
- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …etc. with minimal guidance. + Leads the planning, logistics, and scheduling for CMC Regulatory Affairs Leadership Team meetings and any other similar leadership ... manage managers calendar's (including Pharmaceutical Development & Manufacturing Leadership Team, CMC Regulatory Affairs Leadership Team OOO calendars) + Assists… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …and supports review of documents with impact to Analytical Sciences. + Collaborates with CMC Reg Sci to support regulatory filings + Identifies and implements ... Regeneron is currently looking for an Associate Project Manager to join our QC (Quality Control) AS...day might include the following: + Attends gene therapy CMC program meetings as a representative of Analytical Sciences… more
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