- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in ... various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that data are identified,… more
- 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
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more
- Organon & Co. (Boston, MA)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... in the US + There are **2 openings** The Director , Clinical Pharmacology Lead will be responsible for contributing...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Kelly Services (Boston, MA)
- …the safety profile of gene therapies. 5. **Cross-functional Collaboration** + Collaborate with Regulatory Affairs , Medical Affairs , and Commercial teams to ... studies are designed and conducted to the highest scientific, regulatory , and ethical standards. The VP will lead a...Work closely with senior leadership, the CMO, and the CMC team to integrate clinical insights into product development… more