- Jazz Pharmaceuticals (Palo Alto, CA)
- …plans.Partners with and provides subject matter expertise to key internal functions ( regulatory , Quality, Clinical , CMC and formulations, Product Quality, Drug ... EMA, and ICH guidance documents and GLP regulations.Required experience in authoring non- clinical elements of major regulatory submissions (INDs, CTAs, BLA/NDAs… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …ways to solve problems.Collaborate with Biostatistics [ clinical and medical affairs ], data science, regulatory , clinical development, medical writing, ... clinical studies, and planning the operational aspects of all new clinical studies.The Director will support Integrated Data Analytics and Statistical… more
- DivIHN Integration Inc (Chicago, IL)
- …duration with extension potential (up to 3-4 yrs) Primary Job Function: Supports Global Director of Medical and Scientific Affairs to defining medical affairs ... the following responsibilities under the supervision of the Global Director of Medical and Scientific affairs : Functions...conversations online with GOP leader to give input on clinical trials. Meet with the regulatory team… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …role requires close alignment with the internal stakeholders including Medical Affairs , Commercial, Marketing and Clinical Development groupsEducate payers ... on Twitter. The Sr. MSL will establish and maintain scientific and clinical relationships with medical professionals, researchers, and other members of the… more
- Jazz Pharmaceuticals (Raleigh, NC)
- …researchCross-functional nature of role requires close alignment with the Medical Affairs , Commercial, and Clinical Development groupsDocument and forward ... Pharmaceuticals' products. The MSL will establish and maintain scientific and clinical relationships with medical professionals, researchers, and other members of… more
- University Hospital New Jersey (Newark, NJ)
- …reports to the Administrative Director of the practice and the Executive Director Clinical Operations. Qualifications Licensed as a Registered Nurse in the ... responsible to ensure the safe and effective delivery of patient care and clinical outcomes, compliance with regulatory , administrative, and clinical … more
- 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
