- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Boehringer Ingelheim (Ridgefield, CT)
- …competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for the coordination and execution ... marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal contact for all US … more
- Organon & Co. (Plymouth Meeting, PA)
- …Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist ( Director ) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …team and provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and ... and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic...for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC )… more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area ... as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... into all stages of product development, including preclinical, clinical/medical, CMC , and post-market phases. + Monitor regulatory ...of experience in regulatory affairs , focusing on regulatory … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- Bristol Myers Squibb (San Diego, CA)
- …information. This role will work cross-functionally with several departments (Clinical Operations, CMC , Regulatory Affairs , Supply Chain, Drug Safety/PV, ... to be the global leader in radiopharmaceuticals . The Director , Medical Affairs Research Operations, plays an...are aligned to study specific timelines + Work with regulatory affairs to ensure that all investigator-initiated… more
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