- Fresenius Medical Center (Waltham, MA)
- …be fully remote . **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- Fresenius Medical Center (Waltham, MA)
- This position can be fully remote . **PURPOSE AND SCOPE:** Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions ... and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business. **PRINCIPAL DUTIES… more
- Merck (Boston, MA)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... **Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:** +...not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead. + Develops worldwide… more
- Merck (Boston, MA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...by site or organization, with Friday designated as a remote -working day, unless business critical tasks require an on-site… more
- Merck (Boston, MA)
- …as needed. + Works in partnership with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ functional ... & provides inputs on site selection and validation activities. + Performs remote and on-site monitoring & oversight activities using various tools to ensure:… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May… more