- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:We're looking for a Manager , Regulatory Affairs , Tactical Implementation, on the Regulatory ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical , Medical and Regulatory (CMR) department...Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Senior Medical Information Manager is responsible for contributing to the development and implementation of the Medical ... for their assigned therapeutic area. In addition, the Senior Medical Information Manager leads cross functional teams and initiatives to support Medical Affairs… more
- Eisai, Inc (Nutley, NJ)
- …Medical, Market Access, Corporate Advocacy, HR, IT, Data Governance, Government Affairs , R&D, etc.) in executing both high-priority strategic initiatives (eg, ... medical review committee submissions. Advise on cross-border data transfers (eg, clinical data) and collaborate with global privacy counterparts to ensure compliance… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager , Clinical Research Regulatory Affairs is tasked with oversight ... personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments...and governance of Regulatory Affairs department and involved in the day-to-day support of… more
- ICON Clinical Research (NC)
- …join us on our mission to shape the future of clinical development. Sr Manager , Regulatory Affairs - IVD Location: US Remote, Portland, OR area preferred ... Senior Manager , Regulatory Affairs -... regulatory affairs , including development of regulatory strategies, document writing, marketing authorization applications, clinical… more
- Taiho Oncology (Princeton, NJ)
- …Employee Value Proposition: Join our dynamic and expanding mid-size company as a Sr. Manager , Regulatory Affairs Strategy. In this role, you will support ... learning and professional growth. Position Summary: Under the direction of regulatory affairs management, the incumbent independently prepares and directs… more
- AbbVie (Mettawa, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion ... pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (eg regulatory affairs fellowship, Health Authority, ad promo, etc.) + Preferred… more
- J&J Family of Companies (Irvine, CA)
- …Learn more at https://www.jnj.com/medtech We are searching for the best talent for a ** Manager , Regulatory Affairs ** . _The preferred location for this role ... and relocation assistance is not provided. **Purpose** : The Manager , Regulatory Affairs , is a...experience in another relevant function such as Quality, Medical, Clinical , R&D ( _6+ years with Advanced Degree_ ).… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to...guidelines, policies and regulations + Ethical guidelines of the regulatory profession, clinical research and regulatory… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams. Position will be filled in either ... CA or Parsippany, NJ. **EXAMPLE RESPONSIBILITIES:** + Represents regional Regulatory Affairs or may serve as Regional...Clinical , Nonclinical, Biomarkers). + With guidance, defines the regulatory strategy for one or more Gilead products or… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA...of indications and reimbursement. + Works with Product Development, Clinical Affairs , Quality, Management and other areas… more
- Astellas Pharma (Northbrook, IL)
- …& People Management** + Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in the matrix environment of GRA, ... discipline associated with pharmaceutical development or product oversight; 3 years in regulatory affairs preferred. + Strong scientific knowledge and … more
- PCI Pharma Services (Philadelphia, PA)
- …across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives ... and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting...Control Substances Act. + Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific.… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs ... and much more. Posted Job Title Regulatory Affairs Specialist-CC Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Regulatory Affairs Start-Up Specialist Senior-CC Job Profile Title Clinical Research Regulatory ... regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory...site initiation documentation. Reporting to the Regulatory Affairs New Study & Continuing Review Manager ,… more
- Reckitt (Parsippany, NJ)
- RAS ( Regulatory Affairs Safety) Strategy Manager , Specialty & Allergy City: Parsippany **We are Reckitt** Home to the world's best loved and trusted hygiene, ... Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …local market authorization holders and distributors. **Primary Responsibilities:** + Act as Regulatory Affairs authority for key product registrations with a ... more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish… more
- Teleflex (Houston, TX)
- Clinical Affairs Manager , Interventional Access (REMOTE) **Date:** Dec 8, 2025 **Location:** Houston, TX, US **Company:** Teleflex **Expected Travel** : Up ... lives. **Position Summary** **TRAVEL REQUIRED: 50% (Domestic and International; overnight required)** The Clinical Affairs Manager will provide clinical … more
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