- Actalent (Gaithersburg, MD)
- …therapy experience + Must be located in EST time zone Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of ... to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Merck (Washington, DC)
- …pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and ... **Job Description** The Executive Director , Device Quality & Regulatory will...oversight of product validation, verification, and risk mitigation activities. Regulatory CMC Oversight + Lead the preparation… more
- Merck (Washington, DC)
- …**Reports to** - Director Regulatory Compliance, Device Quality and Regulatory **Location** - Remote , Preference would be to work from Rahway, NJ, ... **Job Description** **Position Title** - Director / Principal Scientist, Regulatory Compliance **Department**...standards. + Provide strategic advice to senior management on CMC regulatory matters based on health authority… more
- Merck (Washington, DC)
- …be drivers of innovation and digitalization, as well as thought directors in CMC (Chemistry, Manufacturing and Controls) data analytics to save and improve lives. ... you will do:** You will be an advocate for CMC statistics and data science and serve as a...evaluate data for submissions and assist with replies to regulatory agencies and pharmacopoeia. You will mentor junior members… more