- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs Team. **How you will contribute:** + As Associate Director, Global Regulatory Project Management and Strategic Planning, you will ... process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **Position Accountabilities:** * Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... the US Medical team, you will report to the Associate Director, Ad/Promo Regulatory Review. You will... regulatory requirements. * Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- …You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Labeling Lead where you will be...+ Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts… 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
- Harvard University (Cambridge, MA)
- …and supporting students through the licensure process. This role reports to the Senior Associate Dean of Academic Affairs and Student Services and is part of ... 65265BRAuto req ID:65265BRJob Code:S0558M FSS Academic Affairs Mgt IV Department Office Location:USA - MA - Cambridge Business Title: Associate Director for… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be… more