- 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
- 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
- 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
- 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
- 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