- Sterling Life Sciences (Sterling, VA)
- …Located in: Maryland A leading company in the biopharmaceutical industry is currently seeking a Director of CMC and Quality to join their team. The role ... the industry - you should not let this opportunity pass by. However, for this Director of CMC and Quality role, you must be someone who is experienced and… more
- Orchard Therapeutics (Menlo Park, CA)
- …path to regulatory application approvals Plan, prepare, and review submissions, including CMC / Quality sections to regulatory authorities (including FDA, EMA and ... Location: Menlo Park (US) Reporting to: VP Regulatory CMC Orchard Therapeutics Limited is a global biotechnology...and other regulatory colleagues to plan and produce high quality regulatory submissions while meeting ambitious timelines With an… more
- PTC Therapeutics, Inc. (South Plainfield, NJ)
- The Associate Director , CMC Medical Writing directs and provides CMC technical support and operational support to the activities of the medical writing staff ... CMC Medical Writing related issues. He/she manages direct report(s). The Associate Director , CMC Medical Writing will collaborate on the development of … more
- Global Blood Therapeutics (San Francisco, CA)
- SENIOR DIRECTOR , REGULATORY AFFAIRS CMC Position Summary: The Senior Director Regulatory Affairs CMC will report to the Vice President Regulatory Affairs ... compliance. Essential Duties and Responsibilities: Lead the Regulatory Affairs CMC group to prepare and submit high- quality ...Affairs CMC group to prepare and submit high- quality regulatory CMC submissions in collaboration with… more
- HireMinds (Boston, MA)
- Our Immuno-Oncology client just north of Boston, MA is looking to add a Director , CMC Regulatory Affairs to their team! This role will oversee and direct all ... chemistry, manufacturing and controls ( CMC ) regulatory strategies for new and mature products. Provide...Provide guidance and support to internal groups such as Quality , Technical Operations, and Analytical as well as to… more
- Daiichi Sankyo (Bernards, NJ)
- …veteran status, age, or any other characteristic protected by law. Job Title Director , CMC Management & Operations City Basking Ridge Functional Area Pharma ... diseases, and other rare diseases. Job Summary: This position will represent CMC development teams on global and regional cross-functional drug development project… more
- Bristol-Myers Squibb Company (Hopewell Township, NJ)
- …employees help to drive innovation and transformative business results. Summary The CMC Regulatory Associate Director is responsible for content development, ... compilation, maintenance, and review of the Quality Module for regulatory submissions to support biotechnology products...HA meetings); &/or post-approval submissions. In this role, the GRS- CMC Associate Director will serve as the… more
- AbbVie (Redwood City, CA)
- …functional areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensure timely execution of high ... approvals and launches. Responsible for the global filings of high quality CMC dossiers, approval and commercialization of products. Bachelor's Degree with at… more
- Molecular Templates, Inc. (Austin, TX)
- …be obtained at www.mtem.com. Position Overview: MTEM requires a highly capable CMC Project Manager to drive successful execution of critical internal and ... ideal candidate for this position must be highly proficient in both technical CMC process and Project Management skills while operating in a fast-paced dynamic… more
- AbbVie (Mettawa, IL)
- …functional areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensure timely execution of high ... approvals and launches. Responsible for the global filings of high quality CMC dossiers, approval and commercialization of products. Basic: Bachelor's Degree… more
- Omeros Corporation (Seattle, WA)
- …is primarily responsible for coordinating the preparation, review, and compilation of CMC filings in support of commercial applications in accordance with ICH ... Your responsibilities in this position will include: Creates/compiles content of CMC documentation to regulatory agencies (NDA/MAA), setting the standards for … more
- Milestone Pharmaceuticals, Inc. (Charlotte, NC)
- …development organizations, CMOs and suppliers, providing project management oversight for CMC , and in accordance with development plans; Execute external development ... Manage formulation and analytical development activities for current and future CMC projects; Review essential elements of scale-up and technology transfer leading… more
- Unknown (Princeton, NJ)
- Prepare/coordinate/file/manage the CMC eCTD content of IND/CTAs, NDA, annual reports, and information amendments for global submission. Participate in the ... review regulatory documents to ensure that all submissions are of high quality . Create and maintain regulatory timelines and track deliverables to timelines to… more
- Job Juncture (Washington, DC)
- My client is seeking a Program Management Director to oversee its pipeline of AAV gene therapy programs. The ideal candidate will take on the following tasks: Plan ... and execute fully integrated CMC plans for developing gene therapy programs Manage operations...IND and BLA filings Experience in tech transfers, manufacturing, quality systems, CMO management, regulatory requirements, and commercial development… more
- JOHNSON & JOHNSON (NJ)
- …pharmaceuticals and demonstrated ability to apply them to author high quality CMC regulatory filings. * Outstanding interpersonal, communication, negotiation, ... Associate Director , Regulatory CMC Dossier Job Description...filings. * Responsible to manage the development of CTD Quality sections to support Regulatory CMC dossier… more
- CSL Behring (King Of Prussia, PA)
- …CSL by becoming a member of our team! Responsibilities The Global Regulatory Affairs (GRA) Director , CMC Strategy Lead - Region North America is a member of the ... (GRA) by: Drives and executes comprehensive, commercially and globally aligned CMC regulatory activities within region for CSL Behring's product portfolio throughout… more
- Xencor, Inc (Los Angeles, CA)
- Director /Sr. Director , CMC Operations -...- with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for ... a Director /Sr. Director , CMC Operations -...Drug Substance contract site selection, cross-functional strategy with supply chain/clinical/ quality /regulatory, group budget, contract site and staff performance, and… more
- ElevateBio (Waltham, MA)
- …developing global regulatory strategies and lead activities in support of submitting high quality CMC regulatory documentation. Here's What You'll Do: - Develop ... Director , CMC Regulatory Manufacturing & Technology...lead at US and EU Agency meetings and support Quality team during GMP and pre-approval inspections - Work… more
- Takeda Pharmaceuticals International GmbH (MD)
- …with Takeda and other employers. See below or here for more info. Associate Director , Global Regulatory Affairs CMC - Marketed Products Takeda fosters a ... only select companies to receive Top Global Employer (R) status for 2019. Associate Director , Global Regulatory Affairs CMC - Marketed Products Job ID R0009112… more
- Remedysolutions (Philadelphia, PA)
- …they pertain to CMC . Liaise with all relevant groups to ensure high quality CMC documentation is developed Lead development of all CTD submission elements ... Director , CMC Regulatory Affairs work remotely...ensuring that they meet current regulatory standards, are high quality , consistent, complete, and approvable on the first review… more
