- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs -...the employment eligibility of all new hires in the United States . Please click on the following… 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
- 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
- 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 ... Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US /EU regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia... Regulatory Operations DIVISION: ADC Diabetes Care LOCATION: United States > Alameda : 1360-1380 South… more
- Eisai, Inc. (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... Transparency Language: The base salary range for the Executive Director , Global Regulatory Affairs -...the employment eligibility of all new hires in the United States . Please click on the following… more
- Kyowa Kirin North America (Princeton, NJ)
- …offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs , Advertising and Promotion Compliance ... assigned product to ensure compliance with US regulatory requirements. In addition, the associate director ...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and...Advisory Board Reports, and strategic Insights Reports to Eisai US and Global Medical Affairs organization.Strengthen Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Olema Oncology (San Francisco, CA)
- …better, longer. For more information, visit us at www.olema.com. About the Role Director , Regulatory Labeling As the Director , Regulatory Labeling, ... reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development...(CCDS), Structured Product Labeling (SPL), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of… more
- Novo Nordisk Inc. (WA)
- …your potential? This role can sit in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex issues that will require an ... locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include a dotted… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the...therapeutic area(s). Collaborate with other stakeholders across Global & US Medical Affairs functions and regions, in… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- …and develop and execute regulatory plans. This position will report to the Director , Regulatory Affairs and collaborate with regulatory and other ... involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- Job Description - AD/Dir Regulatory Affairs Reports To: SR Director - Regulatory Affairs . *Prepare and review various modules of ANDAs, and responses ... in a dynamic environment is required. *In-depth knowledge and experience of regulatory CMC documents review, and approval is required. *Provide regulatory … more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …Supernus products. Essential Duties & Responsibilities: Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this ... and promotional materials for assigned products, submission of materials, and representing Regulatory Affairs on promotional review committee. Acts as primary… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us !The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to...Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...development of American Managed Care Pharmacy (AMCP) dossiers for US payers and Global Value Dossiers for use by… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This role is a national position. Candidates may reside anywhere in the United States . The Position Builds relationships, and differentiates Novo Nordisk ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in… more
