continuity. Cross-Functional Collaboration & Compliance: Work closely with CMC Manufacturing, Quality Assurance, Regulatory.... This is life-changing work, and we are all in, are you? Akebia Therapeutics is seeking a dynamic and experienced Director, Global...
Development, Regulatory, Safety, CMC, Medical Affairs and Commercial, to ensure strategic alignment and seamless execution. Lead... into details at a scientific, medical, development, CMC and commercial level as needed in partnership with the team. Be objective and create...
. See Yourself at Telix We are seeking an experienced leader for the Medical and Technical (CMC) Writing team within Global Regulatory... and driving the regulatory writing process across both clinical and CMC/quality to accelerate the development of diagnostic...
-party service providers, Clinical Research, Legal, IT, Data Management, CMC, Regulatory Affairs, CRAs, Investigators, Study... program and identify and communicate business and regulatory risks. Give guidance and support to Clinical...
and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the... In Place (SIP) capabilities. Reporting to the Director of Engineering, Insulin you will extensively collaborate...
deviations, and ensuring accuracy of regulatory CMC registration details. Develop and implement the CPV program for the site... and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the...
Ability to collaborate with and influence other functional areas such as Manufacturing, Validation and Regulatory Affairs Ability to support..., validation, quality and regulatory functions to support development of molecules leading to commercialization. This Vice...
. This role is highly cross-functional and may involve some travel. Relationships Reports to the Senior Director, Clinical... Pharmacology for the U.S. East Coast Hub. Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory...
and Early Development, Global Translation, Global Medical Affairs, Global Safety (GS), Bioanalysis, CMC and occasionally... some travel. Relationships Reports to the Senior Director, Clinical Pharmacology for the U.S. East Coast Hub. Will interact...
, technology transfer, process validation, technical support for manufacturing, and preparation of CMC documentation for regulatory... located in the US and UK, regulatory affairs, quality, technical writing, and external vendors and suppliers to ensure...