- Teva Pharmaceuticals (West Chester, PA)
- … Affairs, will be responsible to develop and manage detailed regulatory project plans for major global dossiers. The Director that fills this highly ... Director , Regulatory Affairs - Dossier Project Manager...efficient and innovative approaches to successfully deliver on-time and high- quality dossiers. This role requires utilization of in-depth knowledge… more
- Boehringer Ingelheim (St. Joseph, MO)
- …Profile/Target Product Profile and Quality Target Profile. + Provide consistent regulatory advice to project teams regarding the pathways and approaches to ... team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core...to drive Target Product Profile objectives. + Provides consistent regulatory advice to project teams regarding the… more
- Takeda Pharmaceuticals (Boston, MA)
- …following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION DESCRIPTION** : Takeda ... Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with the following duties: Oversee the establishment of … more
- Bayer (NJ)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Director US Regulatory Affairs Liaison** The Director US Regulatory ... registrations. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Regulatory Affairs Liaison, are to: + Demonstrates,… more
- Edwards Lifesciences (Irvine, CA)
- …we are supporting the needs and interests of the patients we serve. The Senior Director , Corporate & Regulatory Counsel role is a blend of subject matter legal ... expert and strong business acumen. The Senior Director , Corporate & Regulatory Counsel will have...legal guidance on the Company and TAVR business's commercial, regulatory , clinical and quality legal issues, this… more
- Lilly (Indianapolis, IN)
- …as appropriate. + Assures that the organization adheres to standards defined in the Regulatory Quality System (RQS). + Assures that key business practices are ... determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the… more
- Ascendis Pharma (Palo Alto, CA)
- …Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area head for ... the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the...as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to… more
- Sanofi Group (Cambridge, MA)
- … regulatory positions and regulatory dossier templates + Act as the Regulatory Affairs-Devices lead on assigned project teams (early phase, late stage and ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and...Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or Morristown, NJ **About… 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 ... of overall regulatory strategy, and communicating with regulatory bodies and clients. The Director will...+ Work directly with client companies and/or FDA without Director or other leadership oversight. + Provide project… more
- Merck (Austin, TX)
- … updates. + Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory ... **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The… more
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