- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Senior Director , Clinical Development & Medical Affairs (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical ... USA501 Additional Locations Bridgewater, NJ 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in… more
- Baystate Health (Springfield, MA)
- …in continuous improvement activities. The Senior Director , Regulatory Affairs works directly with the executive leadership, clinical and administrative ... the direction of the Chief Quality Officer, the Senior Director , Regulatory Affairs directs the...clinical and administrative leaders. + Coordinates formal accreditation, regulatory or licensure on-site surveys. Develops and maintains a… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Thursday, May 30, 2024 Looking for a chance to make a ... assigned to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead...development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs… more
- Merck (Rockville, MD)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety...but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead. +… more
- Ascendis Pharma (Palo Alto, CA)
- The Director , Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical , non- ... 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)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** ... The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible...process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development.… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting...+ Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs , Precision Medicine you will ... need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and...clinical studies. You will provide operational and technical regulatory assistance through all stages of clinical … more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will...for assigned projects to ensure alignment of the regional, clinical and Chemistry Manufacturing and Controls (CMC) regulatory… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... format and information in the development and execution of regulatory submissions. + Ensures accuracy of Clinical ...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory … more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical , Medical and Regulatory (CMR) department...positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- The Director of Clinical Affairs Program Management leads and coordinates program management activities for clinical projects and/or clinical ... Director will work with the representatives from Clinical Affairs functional teams (Site Operations, Lab...Lab Operations, Data Management) to ensure timely deliverables to Regulatory Affairs or other stakeholders. This role… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... vaccine programs in various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams (commercial, … more
- Boehringer Ingelheim (Ridgefield, CT)
- …approach and informs medical affairs efforts where applicable. The Director , Clinical Development Strategy Team Member collaborates cross functionally across ... benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Clinical Development Strategy Team Member is responsible for… more
- J&J Family of Companies (Horsham, PA)
- …Johnson & Johnson is currently seeking an Associate Director , Clinical Scientist to join our world-class Medical Affairs Gastroenterology Therapeutic ... Associate Director , Clinical Scientist- Gastroenterology Therapeutic Area...In this role, you will contribute to world-class Medical Affairs sponsored and supported clinical programs for… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory ... regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control… more
- Hologic (San Diego, CA)
- Senior Director , Clinical Affairs - Diagnostic Solutions San Diego, CA, United States Essential Duties and Responsibilities _This is a full-time San Diego ... for projects, programs and people to maintain and build Clinical Affairs capability for the company (process,...Liaises and communicates with US and International Hologic R&D, Regulatory Affairs , Quality, Marketing, Sales, and other… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs . + Manager level: must have (1-3) years of experience in ... Knowledge and understanding of drug development, including phases of clinical studies, general requirements for drug marketing approval and...the pharmaceutical industry, preferably in Regulatory or Medical Affairs . + Specific experience… more
- Lilly (IN)
- …and one of the most common of all sensory disorders. **Responsibilities:** The Sr. Director , Regulatory Affairs will be responsible for directing ... ranging from newly identified target opportunities to programs in early- and late-stage clinical development. + Lead the development of regulatory strategies for… more