- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs...to support their development + May serve as direct/matrix manager of RAV CMC staff, depending on… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Associate Director ** **; CMC , Device Development Program Manager ** **Functional Area: Technical Operations** At ... 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
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... reporting, & overall first level of project guidance. Relationships Reports into Director , CMC Program Development. Essential Functions + Project Management +… 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 and ... products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs, in collaboration with...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and… more
- AbbVie (Madison, NJ)
- …driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director , or Director , in the development ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison… more
- Ascendis Pharma (Palo Alto, CA)
- …to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global ... will be based in Palo Alto, CA and reports directly to the Senior Director , Regulatory Affairs. Key Responsibilities + Responsible for strategic and operational … more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located in our King of ... is a Hybrid role. You will report to the Director , Regional Regulatory TA Lead. **RESPONSIBILITIES:** +...regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC… more
- Bausch Health (Petaluma, CA)
- …+ Should have good working knowledge of all areas of development - including CMC , non-clinical, clinical, project management and regulatory functions + Will be ... + In concert with the Core Team, the Project Manager will develop, maintain, and drive the project timelines...expected to manage all milestone regulatory filings for development programs from pre-IND briefing packages… more
- Merck (Boston, MA)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory ).** **Expert level skillset ... 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… more
- Merck (Rahway, NJ)
- …for collective success, including quality, operations, engineering, supply chain, regulatory / CMC , commercial, and other manufacturing network sites. **Job ... Biotechnology Support Lead with dotted-line accountability to the regional plant manager (s), where appropriate. The US regional technology transfer lead will be… more
- WuXi AppTec (Middletown, DE)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… more
- Astellas Pharma (Sanford, NC)
- …MSAT, Process Engineering, Process Development, Quality Assurance, Process Sciences, Regulatory , CMC teams, Facilities, Validation, Supply Chain, Quality ... recommend new technologies that will enhance processes. **Organizational Context:** The Material Manager will report to the Associate Director , MSAT &… more
- Rush University Medical Center (Chicago, IL)
- …input to his/her supervisor to identify areas of opportunity within the manager 's scope, escalate risk and resolve barriers. This position will provide direction, ... * Generates Epic and OnCore reports for analysis and communicates findings to Director and team. * Provides resolution of escalated issues, including researching CA,… more
- Billings Clinic (Colstrip, MT)
- …Under clinical supervision of a physician and direct supervision of the Manager / Director , the Nurse Practitioner or Physician Assistant provides general medical ... of their licensure and expertise level of the supervising physician. Colstrip Medical Center ( CMC ) is searching for an APP that is wanting to experience a greater… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by ... Analytical Development and Operations (ADO) organization reports to the Senior Director of Analytical Development (AD). AD is primarily responsible for developing… more
- LA Care Health Plan (Los Angeles, CA)
- …by the Manager and Director . Assists the Member Relations Manager with regulatory audits and requirements. Develops and maintains a positive working ... Business. This includes, but it is not limited to, Medi-Cal, Cal-Medi-Connect ( CMC ), Personal Assistance Services Council (PASC), Healthy Kids, and LA Care Covered… more
- State of Colorado (Canon City, CO)
- …Monthly Location Canon City, CO Job Type Full Time Job Number CAA CMC HP ID&A 2023 Department Department of Corrections Division Clinical and Correctional Services ... valid license from the State of Colorado Department of Regulatory Agencies as an Addiction Counselor Candidate (AC-C) or...establish an eligible list for referral to the hiring manager for final consideration. Be sure the "Work Experience"… more
- Rush University Medical Center (Chicago, IL)
- …Schedule:** 8 Hr (8:00:00 AM - 4:30:00 PM) **Summary:** Reporting to the Director / Manager of Clinical Trials Research Revenue Cycle, this position will create ... overlay in a timely manner. * Review clinical trial protocols and related regulatory documents to prepare a billing plan for all medical procedures and services… more