- 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
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a...be located in Cambridge, MA or Bridgewater, NJ. Hybrid remote working arrangement can also be considered._** Sanofi Inc.… more
- Sanofi Group (Cambridge, MA)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory...be located in Cambridge, MA or Bridgewater, NJ. Hybrid remote working arrangement can also be considered._** Sanofi Inc.… 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
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …Internship opportunities within the Department of Veterans Affairs , please visit: https://www.va.gov/EMPLOYEE/pathways-internship-program/. Incumbent will be given ... program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus...of 2 academic years of post-high school study or associate 's degree in the field of nursing. The required… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** Join Takeda as an Associate Director, Scientific Trainer out of our Lexington, MA office. Where you will be ... supported US Medical therapeutic areas. You will collaborate with Medical Affairs partners (US Medical Strategy, Publications, Medical Communications, and Field… more
- J&J Family of Companies (Boston, MA)
- …closely with leaders in R&D, Supply Chain, Life Cycle Management, Quality, Regulatory Affairs , Finance, Procurement, Packaging, Marketing, and other business ... NA-United States **Organization** Medical Devices & Diagnostics Global Services, LLC (6209) **Job Function** Regulatory Affairs **Req ID:** 2406180116W 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