- Pfizer (Andover, MA)
- …of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the ... help Pfizer develop and implement chemistry, manufacturing and control ( CMC ) regulatory strategies for small and large...of pending registrations and respond to queries. As a Manager , you provide guidance to operational teams for managing… more
- Astellas Pharma (Westborough, MA)
- …remote work are encouraged to apply. **Purpose and Scope:** Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects ... ** Regulatory Manager , Regulatory Affairs - CMC...against regulatory requirements and reviews submissions against regulatory strategy . Ensures proper CMC … more
- Takeda Pharmaceuticals (Boston, MA)
- …transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about ... development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and… more
- Schrodinger (Cambridge, MA)
- …stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory , CMC , and project management to ensure completion ... We are looking to hire a **Senior Manager /Associate Director of Clinical Pharmacology** to join us...can utilize soft skills to guide, lead, and influence strategy /direction of programs + A drug development veteran who… more
- Amazon (North Reading, MA)
- …well-established yet rapidly expanding team. This position reports directly to the Sr Manager of Regulatory Compliance. Key job responsibilities * Applying IEC ... Description We are seeking a Senior Manager for our functional safety engineering development team....will be your job to help drive engineering and strategy for our new and often novel approaches to… more
- Novo Nordisk (Lexington, MA)
- …Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in Clinical Development program(s), Dosage and administration ... strategy , including dose setting and dosing regimen for project(s),...Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development,… more
- Takeda Pharmaceuticals (Boston, MA)
- …and accountable for overarching Global Program(s). The GPL defines the asset strategy and leads all development and Life Cycle Management projects associated with ... speed/cost to market (eg innovative trial designs, improving governance processes, asset strategy etc.) GPLs must + be experienced, versatile and strong enterprise… more
- Takeda Pharmaceuticals (Boston, MA)
- …Previous drug development experience is preferred (eg Medical Affairs, Clinical Research, Regulatory , CMC , or other development related function) + Project ... focus areas necessary to deliver on enterprise wide BD strategy . + Leads the project planning efforts of the...+ 5 to 7 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global… more