- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Friday, June 28, 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
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Director, Regulatory Affairs will be responsible for developing and implementing global ... and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation… more
- Novo Nordisk (Princeton, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide ... About the Department The Clinical , Medical and Regulatory (CMR) department...Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional… 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...In this role, you will contribute to world-class Medical Affairs sponsored and supported clinical programs for… more
- Stryker (Portage, MI)
- …More information is available at www.stryker.com . We are currently seeking an ** Associate ** **Manager, Regulatory Affairs ** to join our **Acute Care ... management, and cross-functional teams. **What you will do** Leads Global Market Operations Regulatory Affairs Team for the Acute care business unit. Performs… more
- Allogene (South San Francisco, CA)
- …LinkedIn. About the role: The Senior Associate will support all aspects of regulatory affairs related to the development of novel CAR T therapies including ... Assist in the authoring, submission, and maintenance of global regulatory submissions related to clinical , CMC and...related field. * Interest in building a career in Regulatory Affairs . * Strong knowledge of eCTD… more
- AbbVie (Irvine, CA)
- …the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence ... https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description The Associate Director of Regulatory Innovation supports … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will… more
- AbbVie (Irvine, CA)
- …meetings. *Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, ... R&D or Industry-related experience *Preferred Experience: 5 years in pharmaceutical regulatory affairs . *Skill Set: Demonstrates effective communication skills… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 4 or More Years of relevant pharmaceutical experience including experience within Regulatory Affairs + Understanding of scientific content and complexities and ... Development and Commercialization process. + Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- SUNY Upstate Medical University (Syracuse, NY)
- …Chief Operating Officer, the Associate Administrator for Hospital Accreditation & Regulatory Affairs and is responsible for oversight and coordination of all ... regulations. In depth knowledge of UH operations and implication on Accreditation. Clinical background preferred. Work Days: Monday to Friday, days - predominately… more
- Fresenius Medical Center (Waltham, MA)
- …can be fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- J&J Family of Companies (Horsham, PA)
- Associate Medical Director, Rheumatology Therapeutic Area - Medical Affairs - 2406188235W **Description** Johnson & Johnson is recruiting for an Associate ... humanity. Learn more at https://www.jnj.com/. As a member of Immunology (IMM) Medical Affairs , the Associate Medical Director, Rheumatology TA will assist in… more
- AbbVie (Mettawa, IL)
- …appropriate scientific and medical activities with internal stakeholders (ie commercial, clinical operations, discovery, statistics, regulatory , etc ) as they ... the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …improve life by advancing the care of patients with life-threatening diseases. ** Associate Director, Public Affairs , US HIV Prevention Communications** Reporting ... closely with cross-functional colleagues in the US Commercial Organization, marketing, Clinical Development, Medical Affairs , Government Affairs , Community… more
- Lilly (Indianapolis, IN)
- …The Associate Vice President (AVP) - Cardiometabolic Health Global Medical Affairs drives strategic planning and, through clinical plans managers, team ... knowledge. Become a patient advocate, as well as a medical expert. 6. Regulatory / submission responsibilities *Ensures that clinical data generated for … more
- AbbVie (Mettawa, IL)
- …design and execution of research using real world data. . Experience with clinical trial methodology, regulatory requirements governing clinical trials and ... our portfolio approach with a unified 'One Immunology' mindset across our medical affairs team. This role is integral to our efforts in creating and implementing… more
- Amgen (Washington, DC)
- … regulatory , CMC, manufacturing, testing or process/product development experience OR Associate 's degree and 10 years of regulatory , CMC, manufacturing, ... The purpose of this position is to support the regulatory , safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development… more
- Cedars-Sinai (CA)
- …yourself, and for others **What you will be doing in this role?** The Associate Director, Medical Affairs is responsible for the administrative oversight and day ... Director of the Office of the CMO and works closely with the Associate Chief Medical Officer/Vice-President of Medical Affairs , other senior executives in… more
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