- Community Medical Center (Point Pleasant, NJ)
- Job Title:RN Location: CMC Nursing Department Name:Medical-Surgical Unit4100/4700 Req #:0000204381 Status:per hour Shift:Night Pay Range: $45.55 - $58.06, per hour ... with the comforts of hometown care. Opened in 1961, CMC has evolved into the state's newest teaching hospital...of practice defined by the Nurse Practice Act and regulatory standards and assures awareness of ethical standards of… more
- Community Medical Center (Asbury Park, NJ)
- Job Title:RN Location: CMC Nursing Department Name:Surgical Unit - II (3B) Req #:0000203506 Status:per hour Shift:Night Pay Range: $45.55 - $58.06, per hour Pay ... with the comforts of hometown care. Opened in 1961, CMC has evolved into the state's newest teaching hospital...of practice defined by the Nurse Practice Act and regulatory standards and assures awareness of ethical standards of… more
- Community Medical Center (Point Pleasant, NJ)
- Job Title: Clinical Research Nurse Location: CMC Nursing Department Name: Oncology Research Department Req #: 0000206888 Status: Salaried Shift: Day Pay Range: ... world-class medical treatment with the comforts of hometown care. Opened in 1961, CMC has evolved into the state's newest teaching hospital with four residency… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Director - CMC Regulatory will leverage CMC technical knowledge and regulatory ... science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the delivery of all relevant… more
- Parexel (Providence, RI)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's ... regulatory leads in developing contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional project meetings and… more
- Merck (Jackson, MS)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... in business process mapping, gap analysis, and workflow optimization for CMC / regulatory authoring. + Practical knowledge of content models/structured content,… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …related subject. The summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed applications in line ... the following:** A summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs...in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus… more
- Taiho Oncology (Princeton, NJ)
- …Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC ... Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI)… more
- AbbVie (Florham Park, NJ)
- … CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and ... FDA) regarding CMC matters. Scope of Responsibility: + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including… more
- Astellas Pharma (Northbrook, IL)
- …work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States ... Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (eg, CMC strategy/planning for… more
- Sanofi Group (Framingham, MA)
- …possible. Ready to get started? **Main Responsibilities:** **Develop and implement global regulatory CMC strategies** + Create strategies for development and ... CMC documentation and submissions** + Write, prepare, review, and approve regulatory CMC dossiers + Ensure dossiers meet quality standards + Comply with … more
- Takeda Pharmaceuticals (Boston, MA)
- …requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market ... and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug ... Building** + Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. + Own continuous improvement of the operating… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …and Controlslead for Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health ... sections of regulatory submissions. + Experience with complex CMC regulatory submissions for both development and marketed products is differentiating.… 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
- Boehringer Ingelheim (Duluth, GA)
- …with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from ... expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development… more
- J&J Family of Companies (Malvern, PA)
- …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... **We are searching for the best talent for a** **Distinguished Scientist, CMC Team Leader, Protein Conjugates** **to be located in** **Malvern, PA or… more
- Regeneron Pharmaceuticals (Troy, NY)
- …manufacturing group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate ... conjugates, peptides). Responsible for end-to-end operational coordination-linking Manufacturing, R&D, CMC , clinical, regulatory -to enable accelerated development and… more
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