- Danaher Corporation (Sunnyvale, CA)
- …which makes everything possible. The Director HR, Regulatory and Clinical Affairs (RACA) will ... be accountable for end-to-end HR leadership for the Regulatory Affairs and Clinical ...where necessary and coaching / mentoring these roles. The Director HR will need to closely work with members… more
- 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
- University of Colorado (Aurora, CO)
- Regulatory Affairs Program Director - 32624 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates ... Institute** **Job Title: Regulatory Affairs Program Director ** **Position...reports) according to set timelines. + Collaborate with other regulatory experts (eg, CMC, nonclinical, clinical ) to… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Type: Permanent Staff (EHRA NF) Vacancy ID: NF0008065 Position Summary/Description: The Director of Regulatory Affairs is responsible for planning, ... further science and the mission of IGHID . The Director of Regulatory Affairs is...in clinical trials management that may include regulatory affairs , clinical trials coordination… more
- Merck (North Wales, PA)
- **Job Description** The Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. +… more
- System One (Deland, FL)
- Position: CONTRACTOR -- Director , US Regulatory Affairs & Global Development Projects (GDP) Location: Remote (East or Central Time Zone) / Prefers local ... 80/hr - 95/hr Purpose and Scope of Position The Director , US Regulatory Affairs &...ensure effective communication and collaboration. Partners closely with R&D, Clinical , Quality and Manufacturing colleagues to provide regulatory… more
- Taiho Oncology (Pleasanton, CA)
- Sr. Director , Regulatory Affairs Strategy...Abilities: + Extensive previous experience in Regulatory Affairs (both US and EU) in clinical ... assigned to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead...and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs Strategy is… 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
- 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
- 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
- Catalent Pharma Solutions (Hillside, NJ)
- **Associate Director , Regulatory Affairs ** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the ... and Catalent employee. The primary duty of the **Associate Director , Regulatory Affairs ** is to...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - West Chester, PA Date: Apr 24, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job ... 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
- Medtronic (Boston, MA)
- …you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team ... be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit... Clinical to determine and execute pre- clinical / clinical test plans in support of regulatory … more
- Battelle Memorial Institute (MA)
- …common. Healthcare innovation is at the core of what we do. Join Battelle as the Regulatory Affairs Director where you will lead and drive the organization's ... regulatory affairs strategy for our Health Business...biologic, device, and drug regulations, including combination products. Demonstrated regulatory strategic planning including nonclinical and clinical … 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
- Bristol Myers Squibb (Madison, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ... ability to apply complex scientific and expert regulatory advice and risk assessment for the development of...risk assessment and mitigation strategies to Commercial Teams, Medical Affairs , Public Affairs , Value Access and Payment,… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology ... Proposition: Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director ,… 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