- Pivotal Solutions (Boston, MA)
- …Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs , and Marketing, to ensure cohesive medical strategies. Scientific ... pharmacovigilance team to ensure the safety of products. Ensure that all Medical Affairs activities comply with regulatory and industry standards. Team… more
- Collabera (Santa Clara, CA)
- …call at ###. Thank you! Pay Rate: $40 - $44/hour Position Details: Industry: Medical Device Position Title: Regulatory Affairs Associate Duration: 12 months ... Description Home Search Jobs Job Description Regulatory Affairs Associate Contract: Santa Clara,...from a regulatory perspective. Strong knowledge of regulatory requirements for medical device labeling. Proficiency… more
- Abbott (Santa Clara, CA)
- …portfolio. The individual will interact with multiple internal cross-functional teams, including R&D, medical affairs , regulatory affairs and finance to ... including clinical project management, clinical operations, clinical science, biostatistics, data management, regulatory affairs , medical affairs as well… more
- Cleerly (Denver, CO)
- … device (SAMD) Minimum 7 years of medical device experience in a regulatory affairs role. Experience in global regulatory submittals and applications for ... and are a growing team of world-class engineering, operations, medical affairs , marketing, and sales leaders. We...in the job description. About the Opportunity As Principal Regulatory Affairs Specialist, you will provide … more
- Randstad (Valencia, CA)
- Regulatory Affairs Manager Medical Device/Pharma client is looking for a Regulatory Affairs Manager to strengthen and help lead their QA/ ... /QA team works very closely together and is highly collaborative, the ideal person has directly managed a team, coached and has experience in regulatory affairs . more
- Takeda Pharmaceutical Company Limited (Cambridge, MA)
- … communication plans through close collaboration with cross-functional teams (including Medical Affairs , Clinical Development, Regulatory Affairs ... Technical/Functional (Line) Expertise: Comprehensive understanding of the pharmaceutical industry and medical affairs Global regulatory expertise with… 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...cross-functional impact, including drug device/combination products and software as medical device platforms.- Reviews and resolves issues that span… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …research and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other ... all phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing).… more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … 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 ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.… 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 ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution ... of Global Medical Affairs /MSL training and continued education plans...credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical… more
- Novo Nordisk Inc. (WA)
- …line with Corporate Tax, as well as other Market Access & Public Affairs teams, Medical , Legal, Compliance, Communications and other key stakeholders locally ... and gathering insights from other departments (Corporate Tax, MA, Comm'l BUs, Medical , Regulatory , Legal, etc) Assigned policy areas may include, but… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory responsibility for field based ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- EPM Scientific (San Diego, CA)
- Title: Senior Specialist/Manager of Regulatory Affairs Summary: A global leader in medical technology is seeking an experienced and driven Regulatory ... If you have strong communication and problem-solving skills and are passionate about regulatory affairs in the medical device industry, this could be the… more
- Merck & Co. (Rahway, NJ)
- …Trial Support, Cross-Functional Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, ... efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical… more
- Cytokinetics (South San Francisco, CA)
- …Job purpose Cytokinetics is seeking an experienced and highly motivated Senior Director, Regulatory Affairs to join the Global Regulatory Affairs ... requirements and industry standards are met. The Senior Director, Regulatory Affairs will lead the Global ...work cross-functionally with Clinical Research, Drug Safety, Biometrics, Quality, Medical Affairs , and others to advance the… more
- Revolution Medicines (Redwood City, CA)
- …mutations in the RAS signaling pathway. The Opportunity: The Associate Director of Regulatory Affairs will independently represent regulatory affairs ... to ensure successful regulatory outcomes. Demonstrate leadership within the regulatory affairs department and cross-functionally to help develop, implement,… more
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