- 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 ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or 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
- 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
- Novo Nordisk Inc. (Boulder, CO)
- …quality, cost & timely completion of all validation deliverables. Relationships Associate Director . Essential Functions Perform, review & approve ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Boehringer Ingelheim (North Brunswick, NJ)
- …Ingelheim has a career opportunity developing pharmaceutical products as a Senior Associate Director , Analytical Development. We are looking for an individual ... materials, to support clinical programs and the preparation of regulatory packages for international product registration activities. In collaboration with… 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
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Associate Director , R&D Master Scheduling Lead? This position is located in our ... King of Prussia PA office. It is a Hybrid role. The Associate Director , R&D Project Planning Capability Lead, is a member of CSL R&D's Project and Portfolio… 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
- Merck (Boston, MA)
- …(as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and ... and packaging activities as well as supply chain documentation to support critical CMC activities. + Support the collection of clinical supply chain metrics and/or… more