- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... short- and long-term business plans, results and follow up Must have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the ... ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are… more
- Vertex Pharmaceuticals (Boston, MA)
- …teams, including R&D, external manufacturing, quality control, vendor quality and regulatory affairs , to align sourcing activities with production schedules, ... produce cell and gene therapy products. This position requires a solid understanding of raw material technology, functionality, specifications, supplier landscapes,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we ... **The opportunity** Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager (Parsippany, NJ)...(ANDA's) and associated amendments, for various dosage forms (solutions, solid oral, semi- solid , or combination products). +… more
- Medtronic (Minneapolis, MN)
- … department and other business functions. This position reports to the Senior Regulatory Affairs Manager . **Role And** **Responsibilities:** + Develop and ... a remote worksite may be considered. The **Senior** **Principal Regulatory Affairs ** will play a key role...issues and submission decisions/content and provide recommendations to the manager for decisions based on business impact. + Ensure… more
- Bausch Health (San Francisco, CA)
- …proven and effective aesthetic care options to consumers and physicians alike. The Manager , Regulatory Affairs provides direct support to Solta operations ... Should have over 7 years of experience as Sr. Regulatory Affairs Specialist. + Should have experience...dossier (Class II or above). + Must have a solid understanding of Change Management / Life Cycle Management… more
- Teva Pharmaceuticals (Weston, FL)
- Regulatory Affairs Associate II Date: Sep 23, 2024 Location: Weston, United States, Florida, 33331 Company: Teva Pharmaceuticals Job Id: 58068 **Who we are** ... to make a difference with. **The opportunity** Actavis Laboratories FL, Inc. seeks a Regulatory Affairs Associate II (Weston, FL) to write, review, and compile… more
- ThermoFisher Scientific (Wilmington, NC)
- …a crucial role in the development of novel and innovative medical devices?** The Regulatory Affairs Manager develops regulatory strategies and supports ... as well as the preparation of marketing applications. The Regulatory Affairs Manager identifies and...or equivalent + Solid understanding of global regulatory requirements and regulatory affairs … more
- Unilever (San Francisco, CA)
- …product claim is backed by solid science. Working hand-in-hand with R&D, Regulatory Affairs , Legal, and Brand teams, they make sure all scientific ... guidelines and legal standards. + Collaborate with the R&D, Regulatory Affairs , Legal, and Brand teams to...San Francisco, CA - Hybrid schedule. HOURS: Full-time, Exempt MANAGER : Senior Scientific Affairs Director … more
- ThermoFisher Scientific (Cincinnati, OH)
- …**Job Description** **Location/Division Specific Information** This position is part of the Regulatory and Clinical Affairs organization which ensures that the ... in vitro diagnostics is in compliance with Good Clinical Practice, applicable regulatory requirements (domestically and internationally) and is submitted to the FDA… more
- AbbVie (Irvine, CA)
- …(MD), PhD, PharmD and/or other higher scientific degree / qualification. + Solid understanding of legal and regulatory guidelines; knowledge of promotional ... Irvine, CA, Marlow, UK, or remotely. What Your New Manager Wants You To Know The Associate Director /...Director / Director, Global Body Contouring, Global Aesthetics Medical Affairs (GAMA) is a key strategic leader in the… more
- Veterans Affairs, Veterans Health Administration (Portland, OR)
- …an open continuous announcement. Qualified candidates will be referred to the Selecting Manager approximately every 14 days from the date of posting until the ... Waste Management Material Handler collecting, processing, packaging, and preparing solid waste/hazardous waste/RMW waste for temporary storage and disposal. Provides… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of success in clinical research field is preferred. + Must have knowledge of regulatory affairs , research ethics and the responsible conduct of research. + ... The Pediatric Solid Tumor Program at Dana-Farber Cancer Institute is...Institute is seeking to hire a motivated Research Project Manager to work within the Clinical Translational Research Program… more
- BeiGene (Emeryville, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at… more
- Duquesne Light Company (Pittsburgh, PA)
- …to date. **Education/Experience Required:** + Bachelor's degree in a relevant field (eg, regulatory affairs , compliance, or a related discipline). + Five or more ... (5+) years of experience in regulatory affairs , compliance, or a related field,...role. Continues to build knowledge base but has a solid foundation to act independently the majority of the… more
- American Academy of Family Physicians (Washington, DC)
- … Specialist will assist the Senior Manager of Federal Policy and Regulatory Affairs with analyzing federal health policy, tracking federal regulations that ... as assigned. The position will report to the Senior Manager , Federal Policy and Regulatory Affairs...with an interest in federal government. Must possess a solid understanding of federal legislative and regulatory … more
- Ascendis Pharma (Palo Alto, CA)
- …Medical Information, and Scientific Alignment. As a member of the Global Medical Affairs team, the Senior Manager , Scientific Alignment will serve as a ... for employees to grow and develop their skills. Scientific Affairs is a key division within Global Medical ...member of the US Legal, Medical, and Regulatory (LMR) review committee, reviewing US Commercial and Medical… more
- Hologic (San Diego, CA)
- …groups. + Aligns with divisional and corporate leadership in Quality Assurance, Regulatory Affairs , Program Management, Finance, Scientific Affairs and ... Sr Manager , Clinical Compliance San Diego, CA, United States...Research Professionals (ACRP), Society of Clinical Research Associates (SoCRA), Regulatory Affairs Certification (RAC), Society for Quality… more
- J&J Family of Companies (Titusville, NJ)
- …medical affairs including collaborating closely with compliance, privacy, and regulatory partners + Build scalable analytics solutions in partnership with Data ... Manager , AI for Medical Engagement - 2406194669W **Description**..., AI for Medical Engagement** to support the medical affairs organization. This position will be located in Horsham,… more
- Abbott (Fairfield, CA)
- …methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and ... and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , R&D, Clinical R&D, Sales and Marketing, Library Services,… more
