- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the ... regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with… more
- Organon & Co. (Plymouth Meeting, PA)
- …Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing ... for assigned products across the product lifecycle. + Identify,?communicate?and escalate?potential regulatory issues to Organon Regulatory CMC management,… more
- Organon & Co. (Plymouth Meeting, PA)
- …Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist ... assigned products across the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- Organon & Co. (Jersey City, NJ)
- …INDs, briefing books and other regulatory documents, as applicable. The Associate Director , Biopharmaceutics will be the primary author for module 2.7.1 ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert...to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other… more
- Organon & Co. (Plymouth Meeting, PA)
- …standards. + Author or review the non-clinical, early clinical development or CMC documentation to support regulatory submissions to regional Health Authorities ... cross-functional development programs with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls… more
- Programmable Medicine Operatin (Redwood City, CA)
- …options. The Company also offers participation in the annual bonus program. At the Associate Director level, the salary range for this position is $160,000 - ... technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to...$185,000 annually. The range for a Director is $185,000 $243,000. We consider various factors when… more
- Endo International (Horsham, PA)
- …everyone we serve live their best life. **Job Description Summary** The Associate Director , Manufacturing Operations will provide leadership and management of ... manufacturing including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- AbbVie (North Chicago, IL)
- …(https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... strong negotiating, influencing, and leadership skills. + Manages completion of CMC regulatory submission documentation for multiple projects of moderate… more
- Kelly Services (South San Francisco, CA)
- …rate:** $60-80/hour Be at the forefront of innovative small molecule drug development as the Associate Director of Project Management, CMC . You will play a ... innovation and operational excellence. You'll work closely with cross-functional leaders across CMC , Drug Development, QA, Regulatory , and external partners to… more
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... medical laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or medical… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory data models, RIM systems (Veeva Vault preferred)** , and Regulatory processes (Labeling, CMC , Registrations). + Excellent analytical and ... the best of my knowledge. **Job Description** **Summary:** The Regulatory Data Governance Lead will ensure Regulatory ...The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with Takeda's… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- AbbVie (North Chicago, IL)
- …automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, work with ... . Provide guidance, technical advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support to laboratory… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: Associate Director -Process Engineer SM API Process Sci** **Location: Cambridge, MA ... (Hybrid)** **About the role:** As an Associate Director -Process Engineer SM API Process Sci,...o Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision… more
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