- Amicus Therapeutics (Marlow, OK)
- Associate Director CMC RA Location Marlow, UK Requisition ID 2246 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1290) Job Brief Associate Director CMC RA Amicus Therapeutics is a… more
- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. ** Associate Director ** **; CMC , Device Development Program Manager** **Functional ... leadership role that collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and influential role in the… 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
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/ Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Boehringer Ingelheim (Ridgefield, CT)
- …advancement of NCE-like Alternative Medicinal Therapeutic Product (ATMP) projects. The Associate Director , Analytical/QC will be responsible for leading ... **Description** The EACD department develops new CMC paradigms for more effective and efficient NCE...(Continued)** + Ensure compliance with all required training, safety, regulatory , HR, intellectual property, GMP's and GLP's (where applicable),… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - West Chester, PA Date: Apr 24, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Sanofi Group (Bridgewater, NJ)
- **Main responsibilities:** + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global ... Regulatory Lead (GRL), the Regulatory Specialist leverages...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Sanofi Group (Bridgewater, NJ)
- …the job** **Our team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages and post marketing to ... a later diagnosis. **Main responsibilities:** + Leads the US regulatory post-marketing activities. + As a key member of...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Sumitomo Pharma (Columbus, OH)
- …and management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting ... ** Associate Director , GMP Quality Control** Sumitomo...for marketed pharmaceutical products or clinical trial materials. Review regulatory IND, IMPD, CTD and BLA/NDA CMC … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …New Modality) team. - Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Merck (West Point, PA)
- …Operations. We are seeking a highly motivated individual for the role of Associate Director , Tech Transfer Leader in Large Molecule Technology Transfer within ... end-to-end scope includes Drug Substance and Drug Product for all large molecules. Associate Director is expected to contribute to ongoing business process… more
- Ascendis Pharma (Palo Alto, CA)
- …of the business, from drug development to marketing. Position Summary The Associate Director of Biostatistics will provide statistical leadership, oversight, ... and activities at CROs. Additional analysis support of non-clinical / biomarker / CMC data and derive insight to contribute to Ascendis' scientific research may… more
- Novo Nordisk (Watertown, MA)
- …drug substance and resolve technical issues or deviations + Author and review relevant CMC sections for US and ex-US regulatory filings, including NDAs + Work ... Development - Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, and Supply… more
- Sanofi Group (Framingham, MA)
- …Culture Development department within CCD located in Framingham, MA in the role of Associate Director . We are looking for a candidate with excellent scientific, ... CMC , communication, and management skills to manage a team...covering FIH to commercial process development, process characterization, and regulatory submissions + Working knowledge of GMP manufacturing +… more
- Merck (Rahway, NJ)
- …the Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director , in ... and timely response to Health Authorities during application review. . Support CMC sections of major, complex regulatory submissions, including Investigation New… 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
- BeiGene (Hopewell, NJ)
- …Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory groups. **Technical/Skills Required:** + Expertise in Green-Field Projects ... production operations at various scales + Familiarity with EMA and FDA regulatory requirements for process development submissions + Broad knowledge of drug… more
- CSL Behring (Pasadena, CA)
- …Phase Product Development stage for Cell and Gene Therapy products. + Ensure regulatory compliance with cGMP, GSP, and other GxP requirements. + Lead tactical ... + Attend and provide Quality oversight for PDETs, Technical Transfer, and CMC meetings for new Product Development projects. + Manage performance and development… more