otherwise intractable classes of proteins as drug targets. Position Senior Director, Global Regulatory Affairs - Chemistry... Manufacturing Controls (CMC) will be responsible for the design, preparation and execution of global regulatory strategies...
Boston, USA Posting date: 26 Mar 2025 Reference: 64877 Senior Director, CMC Regulatory Affairs - Permanent - Boston... intersection of science, strategy, and global regulatory frameworks. As our Senior Director of CMC Regulatory Affairs, you'll play...
are determined to make life better for people around the world. Purpose: The Senior Director of Global Regulatory Affairs – CMC.... Additionally, the Senior Director is committed to fostering continuous improvement in regulatory practices, operational efficiency...
of critical functions as follows: Champions, independently develops and leads the execution of regulatory CMC investigational... regulatory submissions preparation per the GRA CMC Product Team CMC strategy. Combines extensive knowledge of science...
be based in Santa Monica, CA or Gaithersburg, MD and reports to the Senior Director, CMC Regulatory Affairs (CGT). Essential...The Director, Regulatory Affairs - CMC (CGT) is responsible for supporting the development and successful performance...
(CMC) to join the Research & Development team based in Corvallis, Oregon. The Associate Director, Regulatory Affairs...SIGA Technologies, Inc. (www.siga.com) is seeking a full-time (40 hours/week) Associate Director, Regulatory Affairs...
Position Summary The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the.... This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Senior Director, CMC-CGT...
Reporting to the Head of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading... meetings, core submission meetings and other cross functions meetings. Provide global regulatory Affairs-CMC strategic...
of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities... and other cross functions meetings. Provide global regulatory Affairs-CMC strategic guidance to project teams and ensure timely...
applications and post marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts... Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and execution of all regulatory...
achieve our goal of delivering meaningful therapeutics to patients. The Denali Regulatory CMC Director, reporting to the... programs in neurodegenerative diseases. The Regulatory CMC Director is accountable for leading and overseeing global Health...
United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory.... This position will report to the VP, Regulatory Affairs and ideally be based in the Ascendis Pharma corporate offices in Palo...
. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team... diseases. This position will report to the VP, Regulatory Affairs and ideally be based in the Ascendis Pharma corporate offices...
My client is currently seeking a Senior Director of Regulatory Affairs to join their team in Southern CA (Fully Remote...) Description: A position is immediately available for a Senior Director of Regulatory Affairs to provide strategic leadership and direction...
Mammoth BioSciences OPPORTUNITY Mammoth is hiring a(n) (Associate) Director/Sr. Director, Regulatory Affairs... with gene therapy products regulatory requirements Proven success interacting efficiently with Preclinical Research, CMC...
management system. ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director..., Regulatory Affairs and is based in Morristown, New Jersey. RESPONSIBILITIES Primary responsibilities of this role include the...
industrial base. The Impact That You Will Make Senior Regulatory Affairs Consultants are critical to our success... to regulatory strategy, preclinical and clinical study design, CMC, and other topics Draft and review FDA meeting request packages...
Director / Senior Director of CMC. This role is pivotal in ensuring the seamless progression of our diverse pipeline.... Present plans and updates to senior leadership and external stakeholders. CDMO Management: Oversee execution of CMC work...
commercialization. Collaborate with R&D, Manufacturing, Quality, Regulatory Affairs, and other departments to guide program success... strategic guidance for CMC-related regulatory submissions, including IND, BLA, and other regulatory filings. Improve programs...
and marketed product teams. The Opportunity: As a Senior Technical Regulatory Program Director you will lead a significant...-quality CMC regulatory documents to health authorities. This involves staying abreast of internal and external developments...