- Vera Therapeutics (Brisbane, CA)
- Title: Director , Clinical Regulatory Affairs Location: Brisbane About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical -stage biotechnology ... position is specifically responsible for the oversight of regional and global regulatory clinical submissions and to develop strategies to support therapeutic… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Senior Director , Clinical Development & Medical Affairs (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical ... Additional Locations Job Description Summary Job Description The Senior Director , Clinical Development Medical Affairs ...aspects of registration activities with a working knowledge of regulatory affairs , in the development of the… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products...precedent + Lead the planning and implementation of global regulatory filings (eg clinical trial applications, marketing… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference ... incumbent will be assigned to lead/support one or two clinical development programs as Regulatory Lead (RL),...and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares… more
- Amgen (Chicago, IL)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Leader (General ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products...components + Lead the planning and implementation of global regulatory filings (eg clinical trial applications, marketing… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Director , Regulatory Affairs will be responsible for developing and ... and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and ... overseeing data governance strategies and frameworks within the regulatory affairs domain. Regulatory information assets are a core asset for regulatory … more
- AbbVie (Waltham, MA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As an Associate Director of Regulatory Affairs in Chemistry, Manufacturing, and ... In this role, you will build and sustain robust relationships across Regulatory Affairs , Operations, and Research & Development (R&D) functions. You… more
- Lilly (Indianapolis, IN)
- …phase (first in human, Ph1/Ph2) submission experience. + Demonstrated understanding of clinical drug development and regulatory affairs , including ... to evolve how Lilly and LRL operates. The **Senior Director ** is responsible for managing all Regulatory ...college or university + At least 5 years of regulatory affairs experience with research-based drug development,… more