- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** Are you ready ... be critical in helping our teams accelerate progress. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development… more
- Lilly (Indianapolis, IN)
- …better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the scientific and regulatory ... CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly's synthetic molecule portfolio. This role ensures the… more
- Abbott (Maple Grove, MN)
- …diabetes from routine fingersticks. **The Opportunity** We are looking for our next ** Regulatory Operations Compliance Manager** to join our team on-site out of our ... Maple Grove, or St. Paul, MN locations. This Compliance Manager, Global Regulatory Operations would be structured under Global Regulatory Services managing… more
- IQVIA (Columbia, MD)
- MCRA an IQVIA business is seeking an Director, Cardiovascular Regulatory Affairs to be a critical team member supporting regulatory strategy and submissions for ... The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at our ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC** position will work closely...medical fields. + Masters in technical area or MBA; PhD in a technical are or law. + 5+… more
- Lilly (Indianapolis, IN)
- …degree (ie, PhD , PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR + Bachelor's degree with 10+ years ... the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory ... management and explores automation to enhance predictability and repeatability in regulatory processes. We are looking for someone with strong practical experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a critical strategic...seek for this role. **Preferred Education & Experience** + PharmD/ PhD with 2+ years' relevant experience. + MA/MS/MBA with… more
- Globus Medical, Inc. (Audubon, PA)
- …their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, ... and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs...or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience + 5+… more
- Amazon (Sunnyvale, CA)
- …ambitious and complex compliance challenges through research, engagement with regulatory agencies, hands-on testing, debugging, and validation activities. You must ... multiple teams and have a strong ability to navigate the global regulatory compliance schemes to enable market access of consumer electronic products. Additionally… more