- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for Chemical products to join ... Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate ...requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs. + Support complex, non-standard… more
- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs:** **_*This ... site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science,...for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Organon & Co. (Plymouth Meeting, PA)
- … Principal Scientist ( Associate Director ) is responsible for Regulatory Chemistry, Manufacturing and Controls ( CMC ) aspects of clinical phase through ... **Job Description** **The Position** Reporting to the Director in Organon Regulatory Chemistry, Manufacturing...colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as the Associate Director , CMC Program Lead in Allogeneic Cell Therapies. You ... will be responsible to collaborate across Cell Therapy CMC functions and RA functions to deliver CMC pipeline and CMC platform projects. You will sit within… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- AbbVie (Worcester, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... + Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions. Participate in establishing departmental… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs** . The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Associate Director , Global Regulatory Affairs? The job is located in our ... is a hybrid position. You will report to the Director of Global Regulatory Affairs. **Responsibilities:** You...GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking an Associate Director within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. This role will lead clinical and ... and captures efficiencies. + Key contributor to high quality CMC regulatory filings, approvals, and commercialization of drug products. Ensures compliance… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual ... regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide guidance to… more
- Abeona (Cleveland, OH)
- The Associate Director Quality Control (QC) will...overall QC operations + Assist in the preparation of CMC regulatory submissions + Interact with the ... oversee the operation of the QC Microbiology and Transport functions. The Director is responsible for supporting the QC testing, utility and environmental monitoring… more
- Merck (North Wales, PA)
- …& Division organization of our company. ** ** **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking an enthusiastic ** Associate Director , Program & Portfolio Management** to drive programs forward at Regeneron Cell Medicines (RCM) through ... on programs that are in IND-enabling studies through clinical study execution. **As an Associate Director , Program & Portfolio Management at RCM, a typical day… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Program Management, GI2 TAU in our Cambridge, MA office. At ... significant experience within related functions (eg Clinical Science, Clinical Operations, Research, Regulatory , CMC , Marketing) * Minimum of 5 years program… more
- Merck (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- AbbVie (North Chicago, IL)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present ... Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals… more
- AbbVie (North Chicago, IL)
- …functional groups to provide a unified modeling and simulation position to clinical, CMC and regulatory teams. + Responsible for the appropriateness, quality and ... support development plans and strategies to achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD modeling and simulation… more
- OnKure, Inc. (Boulder, CO)
- …development-stage biotech industry standards, and achieves desired compliance with regulatory , clinical, and business operations goals. The ideal Quality Assurance ... Assurance team to provide enhancements to Quality Systems to improve efficiency, regulatory compliance, and reduce manual processes Author and manage to resolution… more
- University of Maryland, Baltimore (Baltimore, MD)
- …This program covers all major areas of drug product and biologics regulatory science, including: Chemistry, Manufacturing, and Controls ( CMC ); Clinical Research; ... of Pharmaceutical Sciences with teaching responsibility to the Graduate Program Director and Associate Dean for Graduate Programs. *_ACADEMIC RESPONSBILITIES… more
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