- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director ... Global Regulatory Affairs CMC. **How you will contribute:**...+ Support submission team members to define CMC content ( data and documentation) requirements for regulatory submissions… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a...a minimum of 1 year (3+ years preferred) of regulatory experience, preferably within the pharmaceutical/ medical device/biotech… more
- Sanofi Group (Cambridge, MA)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...+ Dealt effectively with cross-functional groups, which may include Medical , Legal, Marketing, etc. + Experience managing others is… more
- Abbott (Alameda, CA)
- …Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... . Support functional groups in the development of relevant data to complete a regulatory submission. .... device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality… more
- Abbott (Alameda, CA)
- …**Qualifications** + 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... project plans and timelines. + Lead functional groups in the development of relevant data to complete a regulatory submission. + Write and edit technical… more
- Beth Israel Lahey Health (Boston, MA)
- …Manager of Business and Regulatory Affairs oversees financial performance, regulatory compliance, and data management of the Heart Transplant, LVAD and ... Responsibilities:** 1. Works with the Heart Transplant Director and Medical and Surgical Directors to develop business plans and...adequate electronic systems are in place to capture the data required for submission to regulatory required… more
- Medtronic (Santa Rosa, CA)
- …This position will be based in Santa Rosa, CA. The **Senior Regulatory Affairs Specialist** develops strategies for worldwide product registration with ... in a technical discipline + Minimum 4 years of medical device regulatory experience + Or minimum...our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data , and automation. You're shaping the future of healthcare… more
- Stryker (Cary, IL)
- Stryker is hiring a **Senior** ** Regulatory ** ** Affairs ** **Specialist** to join our Sage ... + Tracks and submits required reports/notifications during clinical research and ensures data supports regulatory strategy and product claims. **What you need:**… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, … more