- Leica Biosystems (Miami, FL)
- …make an impact.Learn about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for ... Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global… more
- Abbott (Alameda, CA)
- …the way people monitor their glucose levels with our new sensing technology. This Senior Regulatory Affairs Manager - APAC position will work closely ... working mothers, female executives, and scientists. The Opportunity This S enior Regulatory Affairs Manager - APAC position will work on-site at our Alameda, CA… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite ... the Abbott Vascular Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the … more
- Fred Hutchinson Cancer Center (Seattle, WA)
- …who bring different and innovative ways of seeing the world and solving problems. The Senior Regulatory Affairs Associate works with faculty and staff in the ... as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs , etc.). Stay abreast of new impacts/areas of knowledge and… more
- BioSpace (Tarrytown, NY)
- Job Details The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with ... responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director. The Senior ... Affairs , Advertising and Promotion Director. The Senior Manager Regulatory Affairs , Advertising… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...health authorities.- Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... on the project team throughout the product lifecycle. Provide senior staff advice and guidance on regulatory ...industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director, Policy. Other internal relationships include a dotted ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- International Staffing Consultants, Inc. (Boston, MA)
- Description SUMMARY The Senior Manager of Regulatory Affairs will lead the regulatory compliance and labeling function, ensuring that products comply ... the Company or industry at large. Lead, mentor, and develop a high-performing regulatory affairs and labeling team, ensuring efficient operations and compliance.… more
- Foresight Diagnostics (Boulder, CO)
- …work diverse schedules, including evenings, weekends, and holidays. This position reports to the Senior Manager of Regulatory Affairs . What You Will Do ... Diagnostics is headquartered in Boulder, Colorado. About The Role The Regulatory Affairs Specialist supports our product teams supporting new product development… more
- Merck & Co. (Upper Gwynedd, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck & Co. (North Wales, PA)
- …areas, including but not limited to, Marketing, Learning & Development, Regulatory Affairs , and LeadershipDemonstrate operational efficiency by leveraging best ... the organization with the mission to achieve business excellence. The RCLO Senior Specialist is responsible for supporting and improving the processes for creation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management o Support the… more
- Eisai, Inc (Nutley, NJ)
- …of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include ... interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and other internal medical… more
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO Leadership Team (LT). ... supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the...and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops… more
- Merck & Co. (North Wales, PA)
- …resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research, and will support Pneumococcal Vaccines.Under the ... guidance of a senior leader, this position supports value evidence outcomes research...is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …based in TN, KY, AR, LA, or MS. Role OverviewAs part of the US Medical Affairs team, the Senior Medical Science Liaison (MSL) will be responsible for engaging ... for research activities, publications, education, consulting, and other Medical Affairs initiatives. The MSL will provide credible, compliant, fair-balanced and… more
