- Lilly (Indianapolis, IN)
- …field from an accredited college or university + At least 7 years of regulatory affairs experience with research-based drug development, including early ... (first in human, Ph1/Ph2) submission experience. + Demonstrated understanding of clinical drug development and regulatory affairs , including regulations in… more
- Takeda Pharmaceuticals (Lexington, MA)
- …PhD, MS, MBA, JD) preferred. + You have a minimum of 4 years' experience in drug , biologic or device Regulatory Affairs or related field, including a minimum ... potential issues. **POSITION ACCOUNTABILITIES:** + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations… more
- Takeda Pharmaceuticals (Lexington, MA)
- …MS, MBA, JD) preferred. + You will have a minimum of 5 years' experience in drug , biologic and/or device Regulatory Affairs or related field, including a ... of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and… more
- AbbVie (North Chicago, IL)
- …expertise across CMC disciplines to further program goals via collaborations with drug product development, regulatory affairs , and commercial operations. ... Research Scientist II to conduct process research and development of antibody- drug conjugates from pre-clinical through clinical development. Job Description We are… more
- Astrix Technology (GA)
- …top-tier talent in Biometrics, Clinical Operations, Drug Safety, Medical Affairs , Regulatory Affairs , Statistical Programming, Clinical Programing, and ... + **Knowledge** : Strong understanding of the clinical research and regulatory affairs landscape, particularly staffing trends and needs. + **Skills**… more
- Ascendis Pharma (Princeton, NJ)
- …of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible for providing commercial ... in drug , biologic and/or combination products in Regulatory Affairs or related field. + Minimum...of 8 years of experience in Regulatory Affairs promotion and advertising working with prescription drug… more
- Amazon (Bellevue, WA)
- …multi-million dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) - . Drug and Biologics regulatory filing ... Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class… more
- AbbVie (Irvine, CA)
- …Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which ... to R&D business stakeholders including but not limited to Pharmacovigilance and Patient Safety, Regulatory Affairs and Medical Affairs to ensure optimal QA… more
- Merck (Philadelphia, PA)
- **Job Description** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy ... point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and...marketed products throughout the entire life cycle of the drug . + Provides leadership as head of the Global… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will require the Fellow ... opportunity to complete rotations in areas within and beyond Regulatory Affairs . The Fellow will be exposed...regulatory trends and developments for their impact on drug and device development activities and on existing development… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) 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
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: + Assist the Manager ... of Regulatory Affairs to create and collate... for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings,… more
- Boehringer Ingelheim (Ridgefield, CT)
- … strategy expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory ... common goals for assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: + Regulatory Professionalism: + As… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** **Live** ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area. Global … more
- SRP (Tempe, AZ)
- College Intern - Regulatory Affairs Location: Tempe, AZ, US Date: Nov 22, 2024 **Requisition ID** : 18074 **Join us in building a better future for Arizona!** ... a graduate student for a paid internship for its Regulatory Affairs department in Tempe, AZ. The...to determine if applicable to the position by management. ** Drug /Alcohol Policy Statement** To promote the safety and well-being… more
- Chiesi (Cary, NC)
- Global Regulatory Affairs Manager Date: Nov 25, 2024 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance & ... Regulatory Affairs Contract Type: Permanent Location: Cary,...into practical application to ensure the success of pre-approval drug development programs. Supports regulatory agency interactions,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory … more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What you will ... do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory … more
- Ascendis Pharma (Palo Alto, CA)
- …workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and implementing global ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- HCA Healthcare (Louisville, KY)
- …of one to care for the lives of many. Jump-start your career as a Regulatory Affairs Coordinator today with Galen College of Nursing. **Benefits** At Galen ... cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free...make a difference. We are looking for a dedicated Regulatory Affairs Coordinator to be a part… more